ELITE EXPANDABLE INTERBODY FUSION DEVICE

Additional Manufacturer Narrative

THE INFORMATION CONTAINED IN THIS REPORT IS BEING PROVIDED TO THE FDA TO COMPLY WITH MEDICAL DEVICE REPORTING REGULATIONS AND IS BASED ON INFORMATION SUBMITTED BY OTHERS THAT MAY NOT BE FACTUALLY CORRECT. THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OF ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR THAT A DEVICE IS RELATED TO AN INJURY OR DEATH. PURSUANT TO MANUFACTURER POLICY, EVENTS RESULTING IN A REVISION SURGERY ARE DEEMED A SERIOUS INJURY AS DEFINED IN 21 CFR 803.3 AND ARE DETERMINED TO BE MDR REPORTABLE EVENTS.

Description of Event or Problem

THE PATIENT UNDERWENT AN INTERBODY FUSION PROCEDURE WITH PLACEMENT OF AN ELITE DEVICE ON (B)(6) 2025. FOLLOWING DEVICE PLACEMENT AND EXPANSION, THE IMPLANT SCREW WAS NOTED DAMAGED AND WAS SUBSEQUENTLY REMOVED FROM THE EXPANDED IMPLANT. APPROXIMATELY ONE (1) MONTH LATER, THE PATIENT RETURNED WITH SYMPTOMS AND IMAGING SHOWED THE INTERBODY IMPLANT HAD COLLAPSED. A REVISION SURGERY WAS CONDUCTED IN WHICH THE IMPLANT WAS REPOSITIONED. FOLLOWING THE REVISION SURGICAL PROCEDURE, THE PATIENT IS REPORTEDLY DOING WELL.