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 specifi