PEPGEN P-15

Additional Manufacturer Narrative

FAILURE TO OSSEOINTEGRATE AND POST-OPERATIVE INFECTION ARE INHERENT RISKS OF THE PROCEDURE KNOWN TO DOCTOR AND PATIENT BEFORE THE PROCEDURE IS INITIATED AND ARE DEPENDENT ON MANY FACTORS INCLUDING THE PATIENT'S AGE, SEX, HEALTH, AND SOCIAL HISTORY, THE TYPE AND SIZE OF THE DEFECT BEING GRAFTED, OCCURRENCE OF SITE PREPARATION TRAUMA (HEAT OR PRESSURE), PRIMARY STABILITY OF THE IMPLANT, AND GRAFT PLACEMENT TECHNIQUE. THOUGH PEPGEN WILL REMODEL TO BONE AT A SIMILAR RATE AS NATURAL BONE IN A PATIENT, IT IS IMPOSSIBLE TO DETERMINE THE SPECIFIC RESORPTION RATE OF ANY BONE GRAFTING MATERIAL; MATERIAL PLACED IN AN AREA OF LOW VASCULARITY AND LITTLE OSTEOGENIC POTENTIAL WILL TAKE MUCH LONGER TO REMODEL TO BONE THAN IF PLACED IN A MORE ACTIVE SITE. CONSIDERING THIS AND THE AVAILABLE INFORMATION, THIS EVENT DOES NOT APPEAR TO BE A RESULT OF A MALFUNCTION OF THE DEVICE. THE IMPLANT LOSS WILL BE REPORTED VIA ASR. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS NOT KNOWN FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW. PLEASE NOTE THIS EVENT AND THE EVENT DOCUMENTED UNDER REPORT NUMBER 1721411-2006-00293 INVOLVE THE SAME PATIENT, DIFFERENT IMPLANT SITES.

Description of Event or Problem

IT WAS REPORTED THAT INFECTION DEVELOPED AND NO OSSEOINTEGRATION WAS ACHIEVED IN A SITE APPROXIMATELY FIVE MONTHS AFTER CONCURRENT PLACEMENT OF PEPGEN P-15 BONE GRAFTING MATERIAL AND AN IMPLANT; IT IS NOT CLEAR IF THE GRAFT INTEGRATED WITH THE SURROUNDING VITAL BONE OR IF IT ALSO FAILED WITH THE IMPLANT. AS A RESULT, IT CAN BE PRESUMED THAT ANOTHER SURGICAL PROCEDURE WOULD BE NECESSARY TO ACHIEVE THE DESIRED RESULTS AND PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE THAT WOULD NOT BE TRIVIAL.