PEPGEN P-15 PUTTY

Description of Event or Problem

IT WAS REPORTED THAT CLINICAL MOBILITY WAS PRESENT, AND NO OSSEOINTEGRATION WAS ACHIEVED IN TWO MANDIBULAR CENTRAL INCISOR SITES, INTO WHICH IMPLANTS AND PEPGEN P-15 PUTTY BONE GRAFTING MATERIAL HAD BEEN CONCURRENTLY PLACED, APPROXIMATELY TWO MONTHS EARLIER. AFTER PLACEMENT, THE IMPLANTS WERE IMMEDIATELY TEMPORIZED AND ADJUSTED TO THE FREE OF CONTACT IN CENTRIC OCCLUSION AND/OR CENTRIC RELATION, AND THE PATIENT WAS INFORMED "NOT TO CHEW ON THE CROWNS;" ALTHOUGH THE IMPLANT WAS "OUT OF FUNCTION," THERE WILL STILL BE MORE LOAD ON THE IMPALNT THAN IF IT WAS SUBMERGED BENEATH THE TISSUE OR AT BONE LEVEL. IT IS NOT CLEAR IF THE GRAFT INTEGRATED WITH THE SURROUNDING VITAL BONE, OR IF IT ALSO FAILED WITH THE IMPLANT, ALTHOUGH THE HEALING TIME IS TOO SHORT TO EXPECT COMPLETE INTEGRATION. 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 WOUILD NOT BE TRIVIAL.

Additional Manufacturer Narrative

FAILURE TO OSSEOINTEGRATE, WHILE UNCOMMON, IS AN INHERENT RISK OF THE PROCEDURE KNOWN TO DOCTOR AND PATIENT BEFORE THE PROCEDURE IS INITIATED AND IS 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 (ALTHOUGH THE DOCTOR STATES THE IMPLANTS WERE PLACED AT TORQUE LEVELS OF 50 N/CM), 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. FROM THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DETERMINE IF THE IMPLANT OR GRAFT WAS THE ETIOLOGY OF FAILURE, THOUGH IT DOES NOT APPEAR THAT THE GRAFTING MATERIAL MALFUNCTIONED. THE IMPLANT LOSSES WILL BE REPORTED VIA ASR. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE CORRECT LOT NUMBER IS NOT KNOWN FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW; THE LOT NUMBER PROVIDED WAS FOUND TO BE INVALID.