Highridge Medical LLC – FDA 483, Mar 1, 2018

An FDA inspection of Zimmer Biomet Spine Inc., located in Westminster, CO, was conducted from February 13 to March 1, 2018. The inspection resulted in a Form FDA 483, identifying critical observations regarding the company's compliance with medical device adverse event reporting regulations. The primary issue was the firm's failure to submit Medical Device Reports (MDRs) within the required 30-day period. Specifically, the FDA observed that approximately 29 MDRs were submitted late for devices that may have caused or contributed to a death or serious injury. Furthermore, about 51 MDRs concerning device malfunctions that could likely lead to death or serious injury if they reoccurred were also submitted beyond the 30-day regulatory deadline. These delays, some extending several months, highlight a lapse in adherence to the regulatory framework for post-market surveillance. Zimmer Biomet Spine Inc. is now expected to address these observations by investigating the underlying causes and implementing comprehensive corrective actions to ensure timely and compliant reporting of all future adverse events.