PEPGEN P-15

Description of Event or Problem

IT WAS REPORTED THAT INFECTION DEVELOPED AND AN IMPLANT HAD CLINICAL MOBILITY IN A SITE INTO WHICH PEPGEN P .15, BIO-OSS, PUROS, BONE PLASTER (CONCOMITANT PRODUCTS NOT MANUFACTURED BY DENTSPLY), AND THE IMPLANT HAD BEEN CONCURRENTLY PLACED APPROX FOUR MONTHS EARLIER. 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 IMPLANT WAS REMOVED AND THE DOCTOR PLANS ON PLACING ANOTHER IMPLANT ONCE THE INFECTION RESOLVES.

Additional Manufacturer Narrative

FAILURE TO OSSEOINTEGRATE, WHILE UNCOMMON, IS AN INHERENT RISK OF THE PROCEDURE KNOWN TO DR AND PT BEFORE THE PROCEDURE IN INITIATED AND IS DEPENDENT ON MANY FACTORS INCLUDING THE PT'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 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 IT 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 DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS NOT KNOWN FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.