PEPGEN P-15 PUTTY

Description of Event or Problem

IN THE EVENT PEPGEN P-15 PUTTY AND A GORE-TEX (NOT MANUFACTURED BY DENTSPLY) MEMBRANE WERE USED SIMULTANEOUSLY WITH IMPLANT PLACEMENT IN THE UPPER LEFT POSTERIOR MAXILLA WITH BONE QUALITY TYPE III AND FAIRE 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 INFECTION PRIOR TO EXPLANTATION THREE MONTHS POST-PLACEMENT. 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 IS TOO SHORT TO EXPECT COMPLETE INTEGRATION, IT IS ALSO NOT CLEAR WHY THE GRAFTING WAS PERFORMED (I.E. IMMEDIATE PLACEMENT, RIDGE AUGMENTATION, ETC).

Additional Manufacturer Narrative

FAILURE OF BONE GRAFTS TO OSSEOINTEGRATE IS AN INHERENT RISK OF THE PROCEDURE, ALTHOUGH UNCOMMON. OTHER VARIABLES TO CONSIDER IN A DIFFERENTIAL DIAGNOSIS, BEYOND PRODUCT (BOTH PEPGEN P-15 PUTTY AND GORE-TEX) NOT PERFORMING TO SPECIFICATIONS, WOULD BE PATIENT HEALTH AND SOCIAL HISTORY (WHICH APPEAR TO BE UNREMARKABLE), SITE PREPARATION TRAUMA (HEAT OR PRESSURE) RESULTING IN NECROSIS OR SCARRING AND FIBROSIS, INSUFFICIENT PRIMARY STABILITY (SECONDARY TO BONE QUALITY AND/OR EXCESSIVE PREPARATION OF THE OSTEOTOMY) RESULTING IN MICRO OR MACRO MOVEMENT, AND INDIVIDUAL GRAFTING TECHNIQUES. FURTHER, IT IS STATED IN THE COMPLAINT THAT THE "PRODUCT APPEARS TO HAVE BEEN EXPIRED BY THE TIME IT WAS IMPLANTED." EXPIRED PRODUCT SHOULD NOT BE IMPLANTED AS ITS STABILITY HAS NOT BEEN VALIDATED BEYOND THE EXPIRATION DATE. FROM THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DEFINITIVELY DETERMINE IF THE IMPLANT, GRAFT, TECHNIQUE, PATIENT COMPLIANCE, SURGICAL COMPLICATION, ADJUNCTIVE PRODUCTS, ETC. WAS THE ETIOLOGY OF FAILURE. HOWEVER, BECAUSE A SECOND SURGERY WAS REQUIRED TO REMOVE AND/OR REPLACE THE IMPLANT AND GRAFT. IMPLANT LOSS WILL BE REPORTED VIA ASR, AS APPROPRIATE. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS NOT KNOWN FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.