PEPGEN P-15

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 FROM THE POSSIBILITY OF CONDENSING TYPE II BONE) 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 COMPLICATIONS (I.E. INFECTON, 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 PER 21 CFR PART 803. 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

IN THIS EVENT PEPGEN P-15 PARTICULATE WAS USED WITH SIMULTANEOUS IMPLANT PLACEMENT IN THE RIGHT POSTERIOR MAXILLA WITH EXCELLENT ORAL HYGIENE AND REPORTED BONE QUALITY TYPE II. THE OSTEOTOMY WAS PREPARED VIA BONE CONDENSING, SOMETHING UNCOMMON WITH TYPE II BONE (ALTHOUGH IT IS POSSIBLE THE DOCTOR IS REFERRING TO THE BONE QUALITY AFTER THE CONDENSING PROCEDURE). IT IS NOT CLEAR IF THE IMPLANT HEALING PHASE WAS SUBGINGIVAL OR TRANSGINGIVAL. THE IMPLANT DID NOT OSSEOINTEGRATE, HAD SIGNS OF MOBILITY, AND WAS EXPLANTED APPROX NINE MONTHS POST-PLACEMENT DURING THE RESTORATIVE /LOADING APPT. IT IS NOT CLEAR IF THE GRAFT WAS INTEGRATING WITH THE SURROUNDING VITAL BONE OR IF IT ALSO FAILED WITH THE IMPLANT.