PEPGEN P-15

Description of Event or Problem

IT WAS REPORTED THAT PEPGEN P-15 WAS USED SIMULTANEOUSLY WITH IMPLANT PLACEMENT IN THE LEFT POSTERIOR MANDIBLE WITH BONE QUALITY TYPE II AND FAIR ORAL HYGIENE. THE OSTEOTOMY WAS PREPARED VIA DRILLING AND HEALING WAS SUBGINGIVAL FOR A TWO-STAGE TREATMENT APPROACH. THE IMPLANT DID NOT OSSEOINTEGRATE AND THE SITE HAD SIGNS OF PROGRESSIVE BONE LOSS UPON EXPLANTATION DURING HEALING, PRIOR TO FUNCTIONAL LOADING; THE LENGTH OF THE HEALING PERIOD IS UNK. 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 DEFINITELY 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. THE IMPLANT LOSS WILL BE REPORTED VIA ASR, AS APPROPRIATE. A DHR REVIEW WAS CONDUCTED FOR THE LOT INVOLVED IN THIS EVENT AS WELL AS THE PREVIOUSLY AND SUBSEQUENTLY MANUFACTURED LOTS. A REVIEW OF BIO-ACTIVITY AND GAMMA STERILIZATION TESTING RECORDS WAS ALSO PERFORMED. BOTH RECORD REVIEWS INDICATE THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATION AND PASSED ALL FINAL ACCEPTANCE CRITERIA. ADDITIONALLY, A REVIEW OF COMPLAINT HISTORY WAS CONDUCTED AND INDICATES THAT NO OTHER COMPLAINTS ASSOCIATED WITH THE LOT INVOLVED IN THIS EVENT HAVE BEEN RECEIVED.