Reported Events Associated With Spine Robots: An Analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience Database.

Abstract

Cross-Sectional Analysis. To summarize medical device reports (MDRs) between August 1, 2017 and November 30, 2021 relating to robot-assisted spine systems within the Manufacturer and User Facility Device Experience (MAUDE) database maintained by The Food and Drug Administration (FDA). The MAUDE database was abstract for all MDRs relating to each FDA-approved robot-assisted spine system. Event descriptions were reviewed and characterized into specific event types. Outcome measures include specific robot-assisted spine systems and reported events as detailed by the MDRs. All data is de-identified and in compliance with the Health Insurance Portability and Accountability Act (HIPAA). There were 263 MDRs consisting of 265 reported events. Misplaced screws represented 61.5% (n = 163) of reported events. Of the 163 reported events, 57.1% (n = 93) described greater than 1 misplaced screw, 15.3% (n = 25) required return to the operating room, 8.6% (n = 14) resulted in neurologic injury, 4.3% (n = 7) resulted in dural tear, and 1.2% (n = 2) resulted in hemorrhage or bleeding. Reported events other than misplaced screws included system imprecision detected prior to screw placement (58/265, 21.9%), mechanical failure (23/265, 8.7%), and software failure (18/265, 6.8%). As more robot-assisted spine systems gain FDA approval and the adoption of these systems continues to grow, documenting and understanding the range of reported events associated with each "tool" is imperative to balancing patient safety with surgical innovation. This study of the MAUDE database provides a unique summary of reported events associated with robot-assisted spine systems that is not directly linked to a research setting.