PEPGEN P-15 PUTTY

Description of Event or Problem

IT WAS REPORTED THAT PEPGEN P-15 PUTTY WAS USED WITH IMPLANT PLACEMENT IN THE LEFT POSTERIOR MANDIBLE IN A PT WITH EXCELLENT ORAL HYGIENE. THE OSTEOTOMY WAS PREPARED VIA DRILLING AND HEALING WAS SUBGINGIVAL. THE IMPLANT DID NOT OSSEOINTEGRATE AND MOBILITY AND INFECTION WERE NOTED UPON EXPLANTATION DURING THE HEALING PERIOD, AFTER FUNCTIONAL LOADING, APPROX SIX MOS POST-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 PROD NOT PERFORMING TO SPECS OR BEING NON-STERILE, TO CONSIDER IN DIFFERENTIAL DIAGNOSIS WOULD BE PT 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 INFO PROVIDED, IT IS NOT POSSIBLE TO DEFINITIVELY DETERMINE IF THE IMPLANT GRAFT, TECHNIQUE, PT 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 LOT # WAS PROVIDED FOR EVAL, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVAL RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.