PEPGEN P-15

Description of Event or Problem

IT WAS REPORTED THAT PEPGEN P-15 PARTICULATE WAS USED SIMULTANEOUSLY WITH IMPLANT PLACEMENT IN THE UPPER LEFT MAXILLA WITH REPORTED BONE QUALITY TYPE II; HEALING WAS SUBGINGIVAL. THE IMPLANT DID NOT OSSEOINTEGRATE AND HAD CLINICAL MOBILITY DURING THE IMPRESSION PHASE WHILE PREPARING TO RESTORE THE IMPLANT. IT IS NOT CLEAR IF THE GRAFT INTEGRATED WITH THE SURROUNDING VITAL BONE, OR IF IT ALSO FAILED WITH THE IMPLANT ALTHOUGH THE HEALING TIME (APPROX FOUR MONTHS) IS TOO SHORT TO EXPECT COMPLETE INTEGRATION. IT IS ALSO NOT CLEAR WHY GRAFTING WAS PERFORMED. (I.E. BONY DEHISCENCE, IMMEDIATE PLACEMENT).

Additional Manufacturer Narrative

FAILURE TO OSSEOINTEGRATE, WHILE UNCOMMON, IS AN INHERENT RISK OF THE PROCEDURE KNOWN TO DR AND PT BEFORE THE PROCEDURE IS INITIATED AND INDEPENDENT ON MANY FACTORS INCLUDING THE PT'S AGE, SEX, HEALTH, AND SOCIAL HISTORY (WHICH APPEARS TO BE UNREMARKABLE OTHER THEN A HISTORY OF SMOKING), THE TYPE AND SIZE OF THE DEFECT BEING GRAFTED, OCCURRENCE OF SITE PREPARATION TRAUMA (HEAT OR PRESSURE) RESULTING IN NECROSIS OR SCARRING AND FIBROSIS, PRIMARY STABILITY OF THE IMPLANT (SECONDARY TO BONE QUALITY AND/OR EXCESSIVE PREPARATION OF OSTEOTOMY), AND GRAFT PLACEMENT TECHNIQUE. THOUGH PEPGEN WILL REMODEL TO BONE AT A SIMILAR RATE AS NATURAL BONE IN A PT, IT IS IMPOSSIBLE TO DETERMINE THE SPECIFIC RESORPTION RATE OF ANY BONE GRAFTING MATERIAL; MATERIAL PLACED IN AN AREA OF LOW VASCULARITY AND LITTLE OSTEOGENIC POTENTIAL WILL TAKE MUCH LONGER TO REMODEL TO BONE THAN IF PLACED IN A MORE ACTIVE SITE. FROM THE INFO PROVIDED, IT IS NOT POSSIBLE TO DETERMINE IF THE IMPLANT OR GRAFT WAS THE ETIOLOGY OF FAILURE, THOUGH IT DOES NOT APPEAR THAT THE GRAFTING MATERIAL MALFUNCTIONED. THE IMPLANT LOSS WILL BE REPORTED VIA ASR. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS NOT KNOWN FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.