PEPGEN P-15

Description of Event or Problem

IT WAS REPORTED THAT PEPGEN P-15 AND OSTEOGRAF N WERE USED WITH SIMULTANEOUS IMPLANT PLACEMENT IN THE MAXILLA WITH BONE QUALITY TYPE III AND FAIR ORAL HYGIENE; THE PT WAS ALSO REPORTED AS BEING A SMOKER. THE OSTEOTOMY WAS PREPARED VIA DRILLING AND HEALING WAS SUBGINGIVAL FOR A TWO-STAGE TREATMENT APPROACH. THE IMPLANT DID NOT OSSEOINTEGRATE AND THE SITE HAD SIGNS OF PROGRESSIVE BONE LOSS UPON EXPLANATION DURING HEALING, APPROX EIGHT 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 IS AN INHERENT RISK OF THE PROCEDURE, ALTHOUGH UNCOMMON. OTHER VARIABLES, BEYOND PRODUCT NOT PERFORMING TO SPECS OR BEING NON-STERILE, 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 AND QUANTITY OF MAXILLARY RIDGE BELOW THE MAXILLARY SINUS) OF THE IMPLANT RESULTING IN MICRO OR MACRO MOVEMENT AND SUBSEQUENT FIBROUS INTEGRATION, INDIVIDUAL GRAFTING TECHNIQUES, AND POST-OPERATIVE COMPLICATION (E.G. INFECTION). FROM THE INFO PROVIDED, IT IS NOT POSSIBLE TO DEFINITIVELY DETERMINE IF THE IMPLANT, GRAFT, TECHNIQUE, PT 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. 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.