PEPGEN P-15

Description of Event or Problem

IT WAS REPORTED THAT AN IMPLANT HAD CLINICAL MOBILITY AND DID NOT OSSEOINTEGRATE APPROXIMATELY FOUR MONTHS AFTER CONCURRENT PLACEMENT OF PEPGEN P-15 BONE GRAFTING MATERIAL AND THE IMPLANT; IT IS NOT CLEAR IF THE GRAFT INTEGRATED WITH THE SURROUNDING VITAL BONE OR IF IT ALSO FAILED WITH THE IMPLANT. AS A RESULT, THE SITE WAS RE-GRAFTED AND ANOTHER IMPLANT SUCCESSFULLY PLACED.

Additional Manufacturer Narrative

FAILURE TO OSSEOINTEGRATE, WHILE UNCOMMON, IS AN INHERENT RISK OF THE PROCEDURE KNOWN TO DOCTOR AND PATIENT BEFORE THE PROCEDURE IS INITIATED AND IS DEPENDENT ON MANY FACTORS INCLUDING THE PATIENT' S AGE, SEX HEALTH, AND SOCIAL HISTORY, THE TYPE AND SIZE OF THE DEFECT BEING GRAFTED, OCCURRENCE OF SITE PREPARATION TRAUMA (HEAT OR PRESSURE), PRIMARY STABILITY OF THE IMPLANT, AND GRAFT PLACEMENT TECHNIQUE. THOUGH PEPGEN WILL REMODEL TO BONE AT A SIMILAR RATE AS NATURAL BONE IN A PATIENT, IT IS IMPOSSIBLE TO DETERMINE THE SPECIFIC RESORPTION RATE OF ANY BONE GRAFTING MATERIAL, MATERIAL PLACE 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. CONSIDERING THIS AND THE AVAILABLE INFORMATION, THIS EVENT DOES NOT APPEAR TO BE A RESULT OF A MALFUNCTION OF THE DEVICE. THE IMPLANT LOSS WILL BE REPORTED VIA ASR. THE LOT NUMBER WAS PROVIDED FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.