PEPGEN P-15 PUTTY

Description of Event or Problem

PEPGEN P-15 PUTTY WAS PLACED SIMULTANEOUSLY WITH AN IMPLANT IN THE UPPER RIGHT POSTERIOR MAXILLA WITH REPORTED BONE QUALITY TYPE II AND FAIR ORAL HYGIENE. OSTEOTOMY PREPARATION APPEARS TO BE VIA BONE EXPANDING SOLELY; BONE EXPANDING / CONDENSING IS GENERALLY LIMITED TO TYPE IV BONE. HEALING WAS TRANSGINGIVAL. THE IMPLANT DID NOT OSSEOINTEGRATE AND HAD CLINICAL MOBILITY PRIOR TO EXPLANTATION, WHICH OCCURRED APPROX TWO WEEKS POST-PLACEMENT. 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 INTEGRATION. IT IS ALSO NOT CLEAR WHY GRAFTING WAS PERFORMED (I.E. BONY DEHISCENCE, IMMEDIATE PLACEMENT, PERI-IMPLANT GAP SUBSEQUENT TO BONE EXPANSION, SINUS AUGMENTATION).

Additional Manufacturer Narrative

FAILURE TO OSSEOINTEGRATE, WHILE UNCOMMON, IS AN INHERENT RISK OF THE PROCEDURE KNOWN TO DOCTOR AND PT BEFORE THE PROCEDURE IS INITIATED AND IS DEPENDENT ON MANY FACTORS INCLUDING THE PT'S AGE, SEX, HEALTH, AND SOCIAL HISTORY (WHICH APPEAR TO BE UNREMARKABLE), THE TYPE AND SIZE OF THE DEFECT BEING GRAFTED, OCCURRENCE OF SITE PREPARATION TRAUMA (HEAT OR PRESSURE NECROSIS SECONDARY TO BONE CONDENSATION) RESULTING IN NECROSIS OR SCARRING AND FIBROSIS, PRIMARY STABILITY OF THE IMPLANT (SECONDARY TO BONE QUALITY AND/OR EXCESSIVE PREPARATION OF OSTEOTOMY), AND GRAFT PLACEMENT TECHNIQUE. THOUGH PEPGEN WILL REMODEL TO BONE AT A SIMILAR RATE AS NATURAL BONE IN A PT, 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 INFO 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. HOWEVER, BECAUSE A SECOND SURGERY WAS REQUIRED TO REMOVE AND/OR REPLACE THE IMPLANT AND GRAFT, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY. 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.