PEPGEN P-15

Description of Event or Problem

IN THIS EVENT PEPGEN P-15 AND BLO-OSS (NOT MANUFACTURED BY DENTSPLY) WERE PLACED PREOPERATIVELY IN A PATIENT WITH EXCELLENT ORAL HYGIENE AND REPORTED BONE QUALITY TYPE II; THE AMOUNT OF TIME THE GRAFT WAS IN PLACE PRIOR TO PLACEMENT OF THE IMPLANT IS NOT KNOWN. THE OSTEOTOMY WAS PREPARED VIA DRILLING AND HEALING WAS TRANSGINGIVAL. THE IMPLANT DID NOT OSSEOINTEGRATE, HAD SIGNS OF CLINICAL MOBILITY, AND WAS EXPLANTED DURING RE-ENTRY APPROX EIGHT MONTHS POST-PLACEMENT. IT IS NOT CLEAR IF THE GRAFT WAS INTEGRATING WITH THE SURROUNDING VITAL BONE OR IF IS ALSO FAILED WITH THE IMPLANT.

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 (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 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 INFO 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 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.