PEPGEN P-15 PUTTY

Description of Event or Problem

IT WAS REPORTED THAT NO OSSEOINTEGRATION WAS ACHIEVED AND AN IMPLANT HAD CLINICAL MOBILITY WITH PROGRESSIVE BONE LOSS IN A SITE INTO WHICH PEPGEN P-15 PUTTY BONE GRAFTING MATERIAL AND THE IMPLANT HAD BEEN CONCURRENTLY PLACED. IT IS NOT CLEAR IF THE GRAFT INTEGRATED WITH THE SURROUNDING VITAL BONE OR IF IT ALSO FAILED WITH THE IMPLANT. IT IS ALSO NOT CLEAR WHY GRAFTING WAS PERFORMED. AS A RESULT, IT CAN BE PRESUMED THT ANOTHER SURGICAL PROCEDURE WOULD BE NECESSARY TO ACHIEVE THE DESIRED RESULTS AND PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE THAT WOULD NOT BE TRIVIAL.

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 (PATIENT IS A SMOKER WITH POOR ORAL HYGIENE), 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 PATIENT, 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 THEN IF PLACED IN A MORE ACTIVE SITE. FROM THE INFORMATION 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.