0539 OAT Device Designs Are Not the Same When it Comes to FDA Adverse Event Reports

Abstract

Abstract Introduction This investigation analyzes whether differences in OAT device designs are associated with different frequencies of adverse event reports (AERs). Methods Each AER identifies the OAT device used by the patient. Each OAT device was characterized using public information. Investigators utilized data from public sources, such as Frost & Sullivan, to estimate prevalence. Results Most frequently reported events were: allergic, swelling, rash and Pain/Discomfort. Only 2.5% of AERs pertained to dental side effects (tooth movements, bite changes). 98.5% of AERs involved OATs made from Lab Materials (acrylics, thermoformed polymers, nylons). 1.5% of AERs involved OATs made from engineered PMMA or Medical Grade Class VI polymers. OATs with Lab Formed materials were an estimated 22.6 times more likely to have an AER than those with Engineered Materials. Components (Herbsts, clasps, screws) comprised 55.6% of AERs. Elastomeric/Nylon Components (straps, bands, rods) comprised 42.4% of AERs. OATs with Monolithic Structures (no components) accounted for 2.0% of AERs. Compared with monolithic OATs, OATs using Metal Components and OATs using Elastomeric/Nylon components were 18.2 and 13.9 times more likely to have an AER. Anterior Clasps Mechanisms, Push Herbsts, Pull straps, bands, rods, 70-Degree Posts, and 90-Degree Twin Posts accounted for 45%, 42.7%, 6.1%, 5.6% and 0.6% of AERs respectively. Compared with 90-Degree Twin Post Mechanisms, Push mechanisms and OATs with Pull Mechanisms were 154 times and 146 times more likely to have an AER. Lab Formed OATs with Liners, Lab Formed Linerless OATs and Precision Engineered Linerless OAT devices accounted for 77.3%, 21.2% and 1.5% of events reported, respectively. OATs with Liners were an estimated 35.5 times more likely to have an AER than Precision Engineered Linerless OATs. Conclusion All OAT device designs are not the same when it comes to AERs. More AERs are associated with reactions. Dental side effects infrequently result in AERs. OAT devices that use Precision Engineered Materials, Monolithic Structures, 90-Degree Twin Posts and Precision Engineered Linerless designs are associated with lower frequencies of AERs. The results of this investigation suggest that medical guidelines and insurance coding should empower therapy providers with the flexibility to prescribe devices that are associated with fewer AERs. Support (if any)