PEPGEN P-15 PUTTY

Description of Event or Problem

IT WAS REPORTED THAT PEPGEN P-15 PUTTY WAS USED SIMULTANEOUSLY WITH IMPLANT PLACEMENT IN THE LOWER LEFT POSTERIOR MANDIBLE WITH BONE QUALITY TYPE I AND FAIR ORAL HYGIENE. THE OSTEOTOMY WAS PREPARED VIA DRILLING AND HEALING WAS SUBGINGIVAL FOR A TWO-STAGE TREATMENT APPROACH. THE IMPLANT DID NOT OSSEOINTEGRATE AND DEMONSTRATED MOBILITY AND INFECTION PRIOR TO EXPLANTATION; THE TIME INTERVAL TO EXPLANTATION IS NOT KNOW, THOUGH IT OCCURRED PRIOR TO LOADING (DURING THE SUBMERGED HEALING PHASE). IT IS NOT CLEAR IF THE GRAFT INTEGRATED WITH THE SURROUNDING VITAL BONE OR IF IT ALSO FAILED WITH THE IMPLANT, NOR IS IT POSSIBLE TO SPECULATE ON HOW MUCH, IF ANY, INTEGRATION OCCURRED AS THE HEALING INTERVAL IS UNK. IT IS ALSO NOT CLEAR WHY GRAFTING WAS PERFORMED (I.E. BONY DEHISCENCE, IMMEDIATE PLACEMENT). AS A RESULT, IT CAN BE PRESUMED THAT 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 DR AND PT BEFORE THE PROCEDURE IS INITIATED AND IS DEPENDENT ON MANY FACTORS INCLUDING THE PT'S AGE, SEX, HEALTH, AND SOCIAL HISTORY (WHICH APPEAR TO BE UNREMARKABLE), 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 THE 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 INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DETERMINE IF THE IMPLANT, GRAFT, TECHNIQUE, PT COMPLIANCE, ETC. 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 EVAL AND THE LOT # IS NOT KNOWN FOR RETAINED-PROD TESTING AND/OR DHR REVIEW.