PEPGEN P-15

Description of Event or Problem

IN THIS EVENT PEPGEN P-15 WAS PLACED PREOPERATIVELY IN THE RIGHT ANTERIOR MAXILLA IN A PT WITH FAIR ORAL HYGIENE AND REPORTED HOME QUALITY TYPE II; THE PT ALSO HAS A HISTORY OF SMOKING. 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 SUBGINGIVAL. INFECTION DEVELOPED AND THE IMPLANT DID NOT OSSEOINTEGRATE, HAD SIGNS CLINICAL MOBILITY, AND WAS EXPLANTED DURING THE HEALING PERIOD APPROX FOUR MONTHS POST-PLACEMENT. IT IS NOT CLEAR IF THE GRAFT WAS INTEGRATING WITH THE SURROUNDING VITAL BONE, OR IF IT ALSO FAILED WITH THE IMPLANT.

Additional Manufacturer Narrative

FAILURE OF BONE GRAFTS TO OSSEOINTEGRATE AND DEVELOPMENT OF INFECTION ARE INHERENT RISKS OF THE SURGICAL PROCEDURE, ALTHOUGH UNCOMMON. OTHER VARIABLES, BEYOND PRODUCT NOT PERFORMING TO SPECIFICATIONS TO CONSIDER IN A DIFFERENTIAL DIAGNOSIS WOULD BE PT 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 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 AND GRAFT, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PART 21 CFR PART 803. THE IMPLANT LOSS WILL BE REPORTED VIA ASR, AS APPROPRIATE. THE DEVICE WAS NOT RETURNED FOR EVAL, AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.