PEPGEN P-15 PUTTY

Additional Manufacturer Narrative

FAILURE OF BONE GRAFTS TO OSSEOINTEGRATE IS AN INHERENT RISK OF THE SURGICAL PROCEDURE, ALTHOUGH UNCOMMON. OTHER VARIABLES, BEYOND PRODUCT NOT PERFORMING TO SPECIFICATIONS, TO CONSIDER IN A DIFFERENTIAL DIAGNOSIS WOULD BE PATIENT HEALTH AND SOCIAL HISTORY (PARTICULARLY SMOKING WHICH IS A KNOWN RISK FACTOR FOR BOTH THE IMPLANT AND GRAFT FAILURE), 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 SUBSEQUENT FIBROUS INTEGRATION, INDIVIDUAL GRAFTING TECHNIQUES, AND POST-OPERATIVE COMPLICATION (I.E. INFECTION, WOUND DEHISCENCE, OR EARLY LOAD FROM TEMPORIZATION OR TRANSGINGIVAL HEALING). FROM THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DEFINITIVELY DETERMINE IF THE IMPLANT, GRAFT, TECHNIQUE, PATIENT COMPLIANCE, POST-OPERATIVE COMPLICATION, ETC. WAS THE ETIOLOGY OF FAILURE. HOWEVER, BECAUSE A SECOND SURGERY WAS REQUIRED TO REMOVE AND/OR REPLACE THE IMPLANT AND GRAFT, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE IMPLANT LOSS WILL BE REPORTED VIA ASR, AS APPROPRIATE. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

Description of Event or Problem

IT WAS REPORTED THAT PEPGEN P-15 PUTTY AND PUROS (NOT MANUFACTURED BY DENTSPLY) WERE PLACED CONCURRENTLY WITH AN IMPLANT IN THE LEFT POSTERIOR MAXILLA IN A PATIENT WITH FAIR ORAL HYGIENE AND REPORTED BONE QUALITY TYPE II; THE PATIENT ALSO HAS A HISTORY OF SMOKING. THE OSTEOTOMY WAS PREPARED VIA DRILLING AND BONE EXPANDING AND HEALING WAS SUBGINGIVAL. THE IMPLANT DID NOT OSSEOINTEGRATE AND WAS EXPLANTED DURING THE HEALING PERIOD; THE IMPLANT WAS IN PLACE FOR AT LEAST TWO MONTHS, THOUGH THE EXACT TIME OF EXPLANATION IS NOT KNOWN. IT IS NOT CLEAR IF THE GRAFT WAS INTEGRATING WITH THE SURROUNDING VITAL BONE OR IF IT ALSO FAILED WITH THE IMPLANT.