Experience Database Research Articles

The Effects of a National Recall on the Reports to the FDA Manufacturer and User Facility Device Experience Database of a Common Atherectomy Device

The HawkOne Directional Atherectomy System (Medtronic Inc., Minneapolis, MN) is a peripheral arterial disease management system that was recalled in December 2021 secondary to repeated guidewire prolapse. We set forth to analyze the patient problems and device issues that caused the device to be recalled and determine if the recall had a significant impact on the device reports utilizing the US Food and Drug Administration (FDA) database Manufacturer and User Facility Device Experience (MAUDE). MAUDE was queried for all adverse report events for the HawkOne device six months prior to and after its recall date in December 2021. Data collected included patient-based issues, device-based issues, and if the device was evaluated by the manufacturer. Fisher's exact test was utilized. There were 72 unique events reported prior to the device recall and 35 events reported after the recall. The majority of adverse events resulted in no adverse clinical outcomes before (55.6%) and after (21.3%) the recall. The most common reported device issue was detachment both before (54.8%) and after (57.1%) the recall. There was no significant difference in the rate of any patient outcome or device problem after the recall. The number of devices evaluated by the manufacturer after the recall was significantly reduced (69.9% vs 11.4%; P ≤ .001). There was no significant change in the rate of specific patient outcomes or device issues after the HawkOne device recall. The rate at which the devices were evaluated by the manufacturer significantly reduced after the recall. These data indicate possible influences that an official device recall might have on reporting to the MAUDE and warrant further study to understand the complexity of user-based feedback of such endovascular devices.

Causes and clinical consequences of inappropriate shocks experienced by patients wearing a cardioverter-defibrillator

The LifeVest® wearable cardioverter-defibrillator (WCD) prevents sudden cardiac death in at-risk patients who are not candidates for an implantable defibrillator. The safety and efficacy of the WCD may be impacted by inappropriate shocks (IAS). The purpose of this study was to assess the causes and clinical consequences of WCD IAS in survivors of IAS events. The Food and Drug Administration's Manufacturers and User Facility Device Experience database was searched for IAS adverse events (AE) that were reported during 2021 and2022. A total of 2568 IAS-AE were found (average number of IAS per event: 1.5 ± 1.9; range 1-48). IAS were caused by tachycardias (1255 [48.9%]), motion artifacts (840 [32.7%]), and oversensing (OS) of low-level electrical signals (473 [18.4%]) (P <.001). Tachycardias included atrial fibrillation (AF) (828 [32.2%]), supraventricular tachycardia (SVT) (333 [13.0%]), and nonsustained ventricular tachycardia/fibrillation (NSVT/VF) (87 [3.4%]). Activities responsible for motion-induced IAS included riding a motorcycle, lawnmower, or tractor (n = 128). In 19 patients, IAS induced sustained ventricular tachycardia or ventricular fibrillation that subsequently were terminated by appropriate WCD shocks. Thirty patients fell and suffered physical injuries. Conscious patients (n = 1905) did not use the response buttons to abort shocks (47.9%) or used them improperly (20.2%). IAS resulted in 1190 emergency room visits or hospitalizations, and 17.3% of patients (421/2440) discontinued the WCD after experiencing IAS, especially multiple IAS. The LifeVest WCD may deliver IAS caused by AF, SVT, NSVT/VF, motion artifacts, and oversensing of electrical signals. These shocks may be arrhythmogenic, result in injuries, precipitate WCD discontinuation, and consume medical resources. Improved WCD sensing, rhythm discrimination, and methods to abort IAS are needed.

44 - Trends and incidence of reported events associated with male slings: An analysis of the food and drug administration’s manufacturer and user facility device experience database

44 - Trends and incidence of reported events associated with male slings: An analysis of the food and drug administration’s manufacturer and user facility device experience database

PO-02-227 ADVERSE EVENTS ASSOCIATED WITH AUTOMATIC EXTERNAL DEFIBRILLATOR - LIFEPAK: A STUDY FROM FOOD AND DRUG ADMINISTRATION MAUDE DATABASE

Automatic External defibrillator (AED) can analyze heart rhythms and allows operators to deliver treatment in patients with tachyarrhythmias or cardiac arrest with a shockable rhythm. The incidence of adverse events (AE) between different ED models is not well known. We sought to assess the type of AE associated with the AED – Lifepak series (Stryker, Kalamazoo, MI) using the FDA Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database is a repository of industry and patient/physician-reported medical device adverse events. A MAUDE database search was conducted on November 10, 2022, for reports received between January 1992 to October 2022 to capture all AE. A total of 32,557 AE were reported from 1992 to 2022. An increase in trends of AE was observed from 1992 to 2022 (0.1% to 7.3%), respectively. Among the 7 Lifepak models, Lifepak CR Plus (5.5%, 1177 events), Lifepak CR2 (5.7%, 1230 events), and Lifepak 20e (5.85%, 1260 events) had the three lowest reported AE while the Lifepak 15 (28.2%, 6073 events), Lifepak 20 (21.2%, 4561 events) and Lifepak 12 (23.6%, 5085 events) had the three highest reported AE (21,503 events). The most commonly reported AE was product malfunction (95.9%, 31,209 events) resulting in patient injury (0.9%, 289 events) and patient death (2.9%, 950 events). Correct utilization of AED is crucial during advanced cardiac life support. Appropriate selection of AED models with clinical situations and operators’ experience is essential.

Clinical Adverse Events and Device Failures Reported for the Captivator and Duette Endoscopic Mucosal Resection (EMR) Systems: A MAUDE Database Analysis.

Endoscopic mucosal resection (EMR) is a widely used technique for the removal of precancerous or select cancerous mucosal-based lesions. Two systems used for EMR of upper gastrointestinal lesions are the Duette EMR kit and the Captivator EMR kit. The aim of this study is to analyze the reports submitted to the Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for patient-related adverse events and device failures associated with these EMR kits. We analyzed postmarketing data from the FDA MAUDE from August 2004 to August 2021. Eighty-four MAUDE reports were found in the study period from August 2004 to August 2021. In total, device issues comprised 36.9% of the reports (n=31) and patient adverse events comprised 63.09% of the reports (n=53). Device issues that were reported included, but were not limited to, band placement/deployment failure (8.1%), suture breakage (7.31%), and snare breakage (4.94%). Patient adverse events that were reported included, but were not limited to, bleeding (25.9%), perforation (7.31%), and snare breakage (4.94%). Captivator EMR and Duette EMR have similar patterns of technical failure and clinical adverse events. More MAUDE reports exist for Duette EMR, possibly due to its longer duration of commercial availability.

MP-453087-5 ADVERSE EVENTS ASSOCIATED WITH AVEIRTMVR LEADLESS PACEMAKER: A FOOD AND DRUG ADMINISTRATION MAUDE DATABASE STUDY

Since the first pacemaker implantation, much of the effort has been focused on battery longevity and device miniaturization. Leadless pacemaker offers an innovative approach to the treatment of bradyarrhythmias, thus avoiding long-term lead-related complications. Recently, the Aveir (screw-in type leadless pacemaker) (Abbott) has been approved by the Food and Drug Administration (FDA). We queried the FDA Manufacturer And User Facility Device Experience (MAUDE) database to study the safety profile and assess the types of complications with this relatively novel device technology. The MAUDE database is a repository of industry and patient/physician-reported medical device adverse events. A MAUDE database search was conducted on November 10, 2022, for reports received post-FDA approval to capture all adverse events. A total of 42 events (after removing duplicate entries or programmer or introducer sheath-related issues n=13) were reported for Aveir leadless pacemaker post-FDA approval. The most frequently reported issue was a device malfunction-related event (n=36, 85.7%). The most commonly encountered problem was the capture issue (28.6%, 12 events), followed by the sensing issue (19%, 8 events), high impedance (19%, 8 events), stretched helix (19%, 8 events), device dislodgement (14.3%, 6 events), device separation failure (14.3%, 6 events), premature separation (4.8%, 2 events), material twist (4.8%, 2 events), and broken helix (2.4%, 1 event). As such, this resulted in pericardial effusion requiring pericardiocentesis (9.5%, 4 events), cardiac perforation (9.5%, 4 events), and arrhythmia (2.4%, 1 event). This resulted in one death. Aveir leadless pacemaker implantation may be complicated by myocardial perforations and tears that result in cardiac tamponade and death. Our study is limited by heterogeneity in reporting, and lack of assessment of the total number of cases performed per year; thus, warranting better transparency and monitoring mechanisms.

PO-05-084 MANAGEMENT OF GRADUAL ELEVATED SHOCK IMPEDANCE IN ENDOTAK RELIANCE ICD LEADS

Elevated shock impedance might indicate structural compromise to implantable cardioverter-defibrillator (ICD) leads. Defibrillation or shock impedance can be measured in two ways: through high output therapy termed true shock impedance (TSI); or through a calculated value using a low voltage sub-threshold measurement (LVSM). We have identified 3 cases of gradual LVSM shock impedance rises (>130 ohm) in patients with Endotak Reliance ICD leads at our institution who subsequently had an open circuit fault code at commanded TSI testing. Literature search revealed case series (Hauser RG et al 2020 and Monkhouse C et al 2019) highlighting this phenomenon. We sought to understand the scope and establish potential recommendations for commanded shock TSI testing in patients with Endotak Reliance ICD leads and high LVSM shock impedance by reviewing cases reported in the FDA Manufacturer and User Facility Device Experience (MAUDE) database. We searched the MAUDE database from 2008 to 2021 for “high impedance” or “impedance problem” while filtering for Endotak Reliance ICD leads. Of these 1369 patients, we identified those who underwent commanded shock testing. The MAUDE search identified 117 ICD leads with high shock impedance (majority > 125 ohm) that underwent DFT or commanded shock. Of those, 69 (59%) had successful DFT or what was deemed as acceptable impedance after commanded shock and remain in service. 18 dual coil leads (15%) underwent shock vector change prior to testing with 16 (87%) of those remaining in service. 30 (26%) of the leads had open circuit fault code, continued high shock impedance or failed defibrillation with testing. These leads were extracted or abandoned with new leads implanted. 1 death was reported as a complication of lead extraction. Endotak Reliance ICD leads can show gradual rise in LVSM shock impedance although the etiology is uncertain. Potential theories include fibrotic encapsulation or calcification of the SVC/RV coil. It is important that these patients are identified, monitored, and risk stratified. We recommend high voltage TSI commanded shock testing in high-risk patients with a gradual rise in LVSM shock impedance that is above the acceptable range. If the impedance is within normal limits during testing, continued surveillance might suffice with repeat testing if further increase in impedance is observed. If the impedance remains elevated with TSI commanded shock testing, then lead replacement should be considered.

A-8 | Modes of Failure of Guide Catheters Extensions: Insights from the Manufacturer and User Facility Device Experience (MAUDE) database

A-8 | Modes of Failure of Guide Catheters Extensions: Insights from the Manufacturer and User Facility Device Experience (MAUDE) database

Adverse Events When Using Advanced Sealing Devices During Vaginal Hysterectomy: An Analysis of the Manufacturer and User Facility Device Experience (MAUDE) Database

Adverse Events When Using Advanced Sealing Devices During Vaginal Hysterectomy: An Analysis of the Manufacturer and User Facility Device Experience (MAUDE) Database

Comparing nationally reported adverse events associated with coblation vs. PlasmaBlade for tonsillectomy

Objective(s)Coblation, or radiofrequency ablation, and pulsed-electron avalanche knife (PEAK) plasmablade are newer approaches for tonsillectomy that reduce exposure to thermal heat. This study aims to describe and compare adverse events related to these devices for tonsillectomy. Study designRetrospective cross-sectional study. SettingThe US Food and Drug Administration's Manufacture and User Facility Device Experience (MAUDE) database. MethodsThe MAUDE database was queried for reports involving coblation devices and the PEAK plasmablade from 2011 to 2021. Data were extracted from reports pertaining to tonsillectomy with and without adenoidectomy. ResultsThere were 331 reported adverse events for coblation and 207 for the plasmablade. For coblation, 53 (16.0 %) of these involved patients and 278 (84.0 %) were device malfunctions. Similarly for the plasmablade, 22 (10.6 %) involved patients and 185 (89.4 %) were device malfunctions. The most frequent patient-related adverse event was burn injury, which was significantly more common with the plasmablade compared to coblation (77.3 % vs. 50.9 %, respectively, p = 0.042). For both the coblator and plasmablade, the most common device malfunction was intraoperative tip or wire damage (16.9 % vs. 27.0 %, respectively, p = 0.010). The Plasmablade tip caught fire in five reports (2.7 %) with one causing burn injury. ConclusionsWhile coblation devices and the plasmablade have demonstrated utility in tonsillectomy with or without adenoidectomy, they are associated with adverse events. Plasmablade use may require greater caution for intraoperative fires and patient burn injuries compared to coblation use. Interventions to improve physician comfort with these devices may help reduce adverse events and inform preoperative discussions with patients.

Patient adverse events and technical failures with the bravo capsule pH system: insights from the MAUDE database.

The BRAVO pH monitor system can benefit patients with ongoing GERD symptoms despite treatment and/or atypical symptoms. We aim to investigate the number and type of complications associated with the BRAVO pH capsule. From April 2016 through February 2021, we analyzed post-marketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database. During the study period, approximately 1,651 reports were identified with 2391 cases associated with a device failure, and 254 reporting a patient-related adverse event. Most device complications were due to aspiration n = 153), followed by reported pain (n = 79), injury (unspecified) (n = 63), and additional radiologic imaging (n = 44). Laceration and bleeding accounted for 29 and 19 cases. Furthermore, three patients suffered perforation. Most device failures were due to loss or failure of the Bravo capsule to bond or adhere to the esophageal mucosa as planned (n = 1269), followed by an activation or positioning failure (n = 972), premature detachment of device (n = 284), and failure of the device to record or transmit data (n = 158). Findings from the MAUDE database highlight the risk of aspiration, hemorrhage/bleeding, perforation, injury, and retention as potential complications of BRAVO capsule placement.

Device Failure and Adverse Events Related to Single-use and Reusable Flexible Ureteroscopes: Findings and New Insights From an 11-Year Analysis of the Manufacturer and User Facility Device Experience Database

To catalog and characterize device failures and adverse events related to flexible ureteroscopes from a national database. Search of the Manufacturer User and Facility Device Experience database was performed for all recorded events related to flexible ureteroscopes between 2012 and 2022. The following information was collected: Problem and cause, timing, complications and injury, prolonged anesthesia, and early termination of procedure. Event severity was graded using a validated tool. A total of 206 events were identified (reusable/single use ratio, 2.5:1). There were 20 different problem categories reported, which included image loss (26.7%), difficulty removing scope (13.6%), scope damage from basket (4.4%), detachment of scope tip (5.8%) and contamination (4.9%). Faulty device was the predominant cause for an event related to single-use scopes (86.4%); this was seldom the case for reusable (2%). Patient injury occurred in 21.8%, but these were all in reusable scopes. No deaths were reported, but major complications included complete avulsion of the ureter (3.4%) and fully entrapped scope necessitating open surgery (2.9%). While the safety profile for single-use scopes was superior, they were significantly more likely to result in early termination (71.1% vs37.3%, P < .001). This was related to 76.3% of the single-usescopes experiencing sudden image loss. Flexible ureteroscopes are fragile, and a multitude of problems can occur. Many of these can be avoided through correct surgeon technique and robust maintenance services.

Typology, Severity, and Outcomes of Adverse Events Related to Angiographic Equipment-A Ten-Year Analysis of the FDA MAUDE Database.

Purpose: Angiographic equipment is a key component of healthcare infrastructure, used for endovascular procedures throughout the body. The literature on adverse events related to this technology is limited. The purpose of this study was to analyze adverse events related to angiographic devices from the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database. Methods: MAUDE data on angiographic imaging equipment from July 2011 to July 2021 were extracted. Qualitative content analysis was performed, a typology of adverse events was derived, and this was used to classify the data. Outcomes were assessed using the Healthcare Performance Improvement (HPI) and Society of Interventional Radiology (SIR) adverse event classifications. Results: There were 651 adverse events reported. Most were near misses (67%), followed by precursor safety events (20.5%), serious safety events (11.2%), and unclassifiable (1.2%). Events impacted patients (42.1%), staff (3.2%), both (1.2%), or neither (53.5%). The most common events associated with patient harm were intra-procedure system shut down, foot pedal malfunction, table movement malfunction, image quality deterioration, patient falls, and fluid damage to system. Overall, 34 (5.2%) events were associated with patient death; 18 during the procedure and 5 during patient transport to another angiographic suite/hospital due to critical failure of equipment. Conclusion: Adverse events related to angiographic equipment are rare; however, serious adverse events and deaths have been reported. This study has defined a typology of the most common adverse events associated with patient and staff harm. Increased understanding of these failures may lead to improved product design, user training, and departmental contingency planning.

PD41-08 DEVICE-RELATED ADVERSE EVENTS DURING BENIGN PROSTATIC HYPERTROPHY SURGERY: REVIEW OF THE MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE DATABASE

You have accessJournal of UrologyCME1 Apr 2023PD41-08 DEVICE-RELATED ADVERSE EVENTS DURING BENIGN PROSTATIC HYPERTROPHY SURGERY: REVIEW OF THE MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE DATABASE Daniel Heidenberg, Ethan Nethery, Nathanael Judge, Kevin Wymer, Scott Cheney, and Mitchell Humphreys Daniel HeidenbergDaniel Heidenberg More articles by this author , Ethan NetheryEthan Nethery More articles by this author , Nathanael JudgeNathanael Judge More articles by this author , Kevin WymerKevin Wymer More articles by this author , Scott CheneyScott Cheney More articles by this author , and Mitchell HumphreysMitchell Humphreys More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003346.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Benign prostatic hyperplasia (BPH) affects most men over 60 years old. The Manufacturer and User Facility Device Experience (MAUDE) database is an FDA maintained public database that contains anonymous, voluntary medical device reports. Herein, we review device-related adverse events reported in the MAUDE database associated with BPH surgeries. METHODS: The MAUDE database was queried for “Aquablation, Rezum, Loop Resection, Morcellator, Greenlight Laser, Holmium Laser, and Urolift” from 2018 through 2021. A complication classification system (Level 1-4) based on the Clavien-Dindo system was used to categorize events based on outcomes. These events were then correlated with device malfunctions and classified as “product related” and “non-product related.” Chi squared analysis was performed to identify associations between BPH surgery type and complication classification distribution. RESULTS: A total of 873 device related events were identified. The entries by surgical subtype included: rezum 304 (35%), urolift 33 (4%), TURP 134 (15%), HOLEP 40 (4%), Aquablation 294 (34%), Greenlight laser 68 (8%). 553 complications (63%) were Level I (mild/none), 138 (16%) were Level II (medical management), 164 (19%) were Level III (surgical management), and 16 (2%) was Level IV (life threatening). The most common level II-IV complications by BPH surgery type: aquablation - hematuria (50%), rezum - lower urinary tract symptoms (23%), HOLEP – retained adenoma (23%), urolift – acute urinary retention (12%), greenlight laser – urethral necrosis (2%), transurethral resection of prostate – bladder perforation (3%). Using chi squared analysis, aquablation (p<0.017) and Rezum (p<0.012) were associated with the highest risk of Level II-IV complications compared with other device classes. Overall, “product related” malfunctions were not associated with level II-IV complications. CONCLUSIONS: Aquablation and rezum were associated with a higher proportion of level II-IV complications. However, this difference is not accounted for by “product related” malfunctions, which highlights surgeon experience or other unknown factors as potential sources for adverse events with newer products. A limitation of this study is the total complications per surgical subtype are not fully captured. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1061 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Daniel Heidenberg More articles by this author Ethan Nethery More articles by this author Nathanael Judge More articles by this author Kevin Wymer More articles by this author Scott Cheney More articles by this author Mitchell Humphreys More articles by this author Expand All Advertisement PDF downloadLoading ...

MP37-02 SACRONEUROMODULATION SAFETY REPORTING: AN ANALYSIS OF THE FDA MAUDE DATABASE

You have accessJournal of UrologyCME1 Apr 2023MP37-02 SACRONEUROMODULATION SAFETY REPORTING: AN ANALYSIS OF THE FDA MAUDE DATABASE Caitlin Carlton, Colby Souders, Nathan Chertack, Ramy Goueli, Gary Lemack, Jennifer Anger, Lynn McClelland, and Maude Carmel Caitlin CarltonCaitlin Carlton More articles by this author , Colby SoudersColby Souders More articles by this author , Nathan ChertackNathan Chertack More articles by this author , Ramy GoueliRamy Goueli More articles by this author , Gary LemackGary Lemack More articles by this author , Jennifer AngerJennifer Anger More articles by this author , Lynn McClellandLynn McClelland More articles by this author , and Maude CarmelMaude Carmel More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003275.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Over 350,000 sacral neuromodulation (SNM) devices have been implanted since approval by the FDA in 1998 (Medtronic, 2022). SNM technology and clinical applications have evolved, with minimal safety updates after initial trials. Here, we provide an updated on real-world SNM safety. These insights will guide informed consent, preoperative counseling, and patient expectation-setting. METHODS: The FDA Manufacturer and User Facility Device Experience (MAUDE) database is a repository for medical device safety reports. We performed MAUDE categorical (1/1/98-12/31/10) and keyword (1/1/11-9/30/21) searches for “Interstim”. A random sample of 1,000 reports was reviewed and categorized by theme. To corroborate this analysis, a legal librarian searched the Public Access to Court Electronic Records database, as well as Bloomberg Law’s dockets database for all lawsuits related to SNM devices. RESULTS: Our search of the MAUDE database returned 44,122 SNM-related AEs. Figure 1 illustrates the prevalence of event categories in the random sample. The largest proportion of reports (25.6%) related to a patient’s need for assistance with device use followed by loss/change of efficacy (19.0%). Interestingly, a fall preceded issue onset in 32% of non-shock pain, 30% of lead/device migration, and 27% of painful shock reports. Our legal search revealed only 4 lawsuits: patient complications after off-label SNM device use, transverse myelitis after implant, device migration or poor placement, and a claim of device malfunction requiring removal and causing permanent injury. CONCLUSIONS: This review confirms the real-world safety and very low complication rates of SNM devices, as seen in clinical trials. We found that 43.3% of SNM “complications” are not AEs, but rather reflect a need for improved technical support or more comprehensive informed consent to convey known device limitations to the patient. Similarly, the number of lawsuits is shockingly low for a device that has been on the market for 24 years, reinforcing the safety of the device. Legal cases involving SNM devices seem to relate to inappropriate patient selection—including at least one case in which SNM was used for a non-FDA approved indication—lack of appropriate follow-up, and/or provider inability to assist the patient with utilizing the device after implantation. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e513 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Caitlin Carlton More articles by this author Colby Souders More articles by this author Nathan Chertack More articles by this author Ramy Goueli More articles by this author Gary Lemack More articles by this author Jennifer Anger More articles by this author Lynn McClelland More articles by this author Maude Carmel More articles by this author Expand All Advertisement PDF downloadLoading ...

Are all Cages Created Equal? Analysis of Cervical Cage Malfunctions Using FDA MAUDE Database.

Retrospective case series. To characterize failure rates of cervical cages based on manufacturer and design characteristics using the nationwide database of reported malfunctions. The Food and Drug Administration (FDA) aims to ensure the safety and efficacy of cervical interbody implants postimplantation; however, intraoperative malfunctions may be overlooked. The FDA's Manufacturer and User Facility Device Experience database was queried for reports of cervical cage device malfunctions from 2012 to 2021. Each report was categorized based on the failure type, implant design, and manufacturer. Two market analyses were performed. First, "failure-to-market share indices" were generated by dividing the number of failures per year for each implant material by its yearly US market share in cervical spine fusion. Second, "failure-to-revenue indices" were calculated by dividing the total number of failures per year for each manufacturer by their approximate yearly revenue from spinal implants in the US. Outlier analysis was performed to generate a threshold value above which failure rates were defined as greater than the normal index. In total, 1336 entries were identified, and 1225 met the inclusion criteria. Of these, 354 (28.9%) were cage breakages, 54 (4.4%) were cage migrations, 321 (26.2%) were instrumentation-related failures, 301 (24.6%) were assembly failures, and 195 (15.9%) were screw failures. Poly-ether-ether-ketone implants had higher failure by market share indices for both migration and breakage compared with titanium. Upon manufacturer market analysis, Seaspine, Zimmer-Biomet, K2M, and LDR exceeded the failure threshold. The most common cause of implant malfunction was breakage. Poly-ether-ether-ketone cages were more likely to break and migrate compared with titanium ones. Many of these implant failures occurred intraoperatively during instrumentation, which underscores the need for FDA evaluation of these implants and their accompanying instrumentation under the appropriate loading conditions before commercial approval.

Invited commentary: Mortality associated with the use of stapler devices and clip appliers: Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience database

Invited commentary: Mortality associated with the use of stapler devices and clip appliers: Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience database

Assessment of adverse events for a home-use intense pulsed light hair removal device using postmarketing surveillance.

Home-use intense pulsed light (IPL) hair removal devices are convenient for consumers. Consumer safety associated with home-use IPL devices, however, remains a subject of interest. In this descriptive analysis, we assessed the most commonly reported adverse events (AEs) for a home-use IPL device from postmarketing surveillance and qualitatively compared these with AEs from clinical studies and medical device reports of home-use IPL treatments. For this analysis of voluntary reports, we queried a distributor's postmarketing database for IPL devices for the period beginning January 1, 2016, to December 31, 2021. All sources of comments, for example, phone, e-mail, company-sponsored web sites, were included in the analysis. AE data were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology. Also, we conducted a PubMed search to identify AE profiles from existing literature on home-use IPL devices and we searched the Manufacturer and User Facility Device Experience (MAUDE) database for reports on home-use IPL devices. These results were qualitatively compared to the data in the postmarketing surveillance database. A total of 1692 cases involving IPL were identified from voluntary reports of AEs between 2016 and 2021. The shipment-adjusted reporting rate for AE cases (number of AE cases/100,000 shipped IPL devices) was 67/100,000 during this 6-year period. The most commonly reported AEs were pain of skin 27.8% (470/1692), "thermal burn" 18.7% (316/1692), and erythema 16.0% (271/1692). Among the top 25 AEs reported, no unexpected health events were observed. The reported AEs were qualitatively similar to the pattern seen in clinical studies and the MAUDE database associated with such home-use IPL treatments. This is the first such report documenting AEs for home-use IPL hair removal from a postmarketing surveillance program. These data are supportive of the safety of such home-use low-fluence IPL technology.

Metal-Free Cortico-Pedicular Device for Supplemental Fixation in Lumbar Interbody Fusion

Pedicle screw fixation is a commonly utilized adjunct for lumbar interbody fusion, yet risks include screw malposition, pullout, loosening, neurovascular injury, and stress transfers leading to adjacent segment degeneration. This report describes the preclinical and initial clinical results of a minimally invasive, metal-free cortico-pedicular fixation device used for supplemental posterior fixation in lumbar interbody fusion. Safety of arcuate tunnel creation was evaluated in cadaveric lumbar (L1-S1) specimens. A finite element analysis study evaluated clinical stability of the device to pedicular screw-rod fixation at L4-L5. Preliminary clinical results were assessed by analysis of Manufacturer and User Facility Device Experience database complications, and 6-month outcomes in 13 patients treated with the device. Among 35 curved drill holes in 5 lumbar specimens, no breaches of the anterior cortex were identified. The mean minimum distance from the anterior surface of the hole to the spinal canal ranged from 5.1mm at L1-L2 to 9.8mm at L5-S1. In the finite element analysis study, the polyetheretherketone strap provided comparable clinical stability and reduced anterior stress shielding compared to the conventional screw-rod construct. The Manufacturer and User Facility Device Experience database identified 1 device fracture with no clinical sequelae among 227 procedures. Initial clinical experience showed a 53% decrease in pain severity (P= 0.009), a 50% decrease in Oswestry Disability Index (P < 0.001), and no device-related complications. Cortico-pedicular fixation is a safe and reproducible procedure that may address limitations of pedicle screw fixation. Longer term clinical data in large clinical studies are recommended to confirm these promising early results.

Insulin Pump-Associated Adverse Events: A Qualitative Descriptive Study of Clinical Consequences and Potential Root Causes.

Objective: To explore the clinical consequences and potential root causes of insulin pump-associated adverse events (AEs) reported in the Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database. Research Design and Methods: Qualitative template analysis of narrative data in a 20% stratified random sample (n = 2429) of reported AEs that occurred during the first 6 months of 2020 involving five insulin pump models marketed at that time: (1) MiniMed™ 670G, (2) MiniMed™ 630G, (3) Omnipod®, (4) Omnipod DASH®, and (5) t:slim X2™. Results: Of the 2429 AEs, 92% included a clinical consequence in the narrative description, with critical hyperglycemia (i.e., blood glucose [BG] >400 mg/dL; 47%) and critical hypoglycemia (i.e., BG <54 mg/dL; 24%) being the most common consequence cited. Only 50% of the AE narratives included information to support the identification of a root cause. The most cited root cause informing remarks were issues with the pump or pod reservoir/cartridge (9%), the occurrence of an obstruction of flow alarm (8%), and problems with the infusion set or site (8%). Some clinical consequences and root cause informing remarks were cited more frequently in AE narratives involving specific insulin pump models, but manufacturer variability in the amount and type of information reported may have affected these findings. Conclusions: Our findings show general themes found in insulin pump-associated AE that providers can use to raise patient awareness of potential risks associated with insulin pump use and develop strategies to prevent future AEs. Improvements in AE investigation and reporting processes are still necessary.