PEPGEN P-15

Description of Event or Problem

IT WAS REPORTED THAT AN IMPLANT WAS LOST APPROXIMATELY FIVE MONTHS AFTER PLACEMENT INTO A SITE, WHICH WAS PREOPERATIVELY GRAFTED WITH PEPGEN P-15, AN UNKNOWN TIME PRIOR TO IMPLANT PLACEMENT. IT IS NOT CLEAR IF THE GRAFT WAS INTEGRATING WITH THE SURROUNDING VITAL BONE OR IF IT ALSO FAILED WITH THE IMPLANT.

Additional Manufacturer Narrative

FAILURE OF BONE GRAFTS TO OSSEOINTEGRATE IS AN INHERENT RISK OF THE PROCEDURE, ALTHOUGH UNCOMMON. OTHER VARIABLES, BEYOND PRODUCT NOT PERFORMING TO SPECIFICATIONS OR BEING NON-STERILE, TO CONSIDER IN A DIFFERENTIAL DIAGNOSIS WOULD BE PATIENT HEALTH AND SOCIAL HISTORY(WHICH APPEAR TO BE UNREMARKABLE), SITE PREPARATION TRAUMA (HEAT OR PRESSURE) RESULTING IN NECROSIS OR SCARRING AND FIBROSIS, INSUFFICIENT PRIMARY STABILITY (SECONDARY TO BONE QUALITY AND/OR EXCESSIVE PREPARATION OF THE OSTEOTOMY AND QUANTITY OF MAXILLARY RIDGE BELOW THE MAXILLARY SINUS) OF THE IMPLANT RESULTING IN MICRO OR MACRO MOVEMENT AND SUBSEQUENT FIBROUS INTEGRATION, INDIVIDUAL GRAFTING TECHNIQUES, AND POST-OPERATIVE COMPLICATION (E.G. INFECTION). FROM THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DEFINITIVELY DETERMINE IF THE IMPLANT, GRAFT, TECHNIQUE, PATIENT COMPLIANCE, POST-OPERATIVE COMPLICATION, ETC. WAS THE ETIOLOGY OF FAILURE. HOWEVER, BECAUSE A SECOND SURGERY WAS REQUIRED TO REMOVE AND/OR REPLACE THE IMPLANT AND GRAFT, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE IMPLANT LOSS WILL BE REPORTED VIA ASR, AS APPROPRIATE. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.