PEPGEN P-15

Description of Event or Problem

IT WAS REPORTED THAT PEPGEN P-15 WAS USED SIMULTANEOUSLY WITH IMPLANT PLACEMENT IN A PT WITH BONE QUALITY TYPE II AND FAIR ORAL HYGIENE. THE OSTEOTOMY WAS PREPARED VIA DRILLING AND HEALING WAS TRANSGINGIVAL. THE IMPLANT DID NOT OSSEOINTEGRATE, HAD SIGNS OF MOBILITY, AND WAS LOST DURING RE-ENTRY, APPROXIMATELY FOUR MONTHS POST-PLACEMENT. IT IS NOT CLEAR IF THE GRAFT WAS INTEGRATING WITH THE SURROUNDING VITAL BONE OR IF IT ALSO FAILED WITH THE IMPLANT. FAILURE OF BONE GRAFTS TO OSSEOINTEGRATE IS AN INHERENT RISK OF THE PROCEDURE, ALTHOUGH UNCOMMON.

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 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, 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. THE IMPLANT LOSS WILL BE REPORTED VIA ASR, AS APPROPRIATE. THE LOT NUMBER WAS PROVIDED, THOUGH THE INVESTIGATION IS NOT COMPLETE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.