PEPGEN P-15 PUTTY

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) 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. A DHR REVIEW WAS CONDUCTED FOR THE LOT INVOLVED IN THIS EVENT AS WELL AS THE PREVIOUSLY AND SUBSEQUENTLY MANUFACTURED LOTS. A REVIEW OF BIO-ACTIVITY AND GAMMA STERILIZATION TESTING RECORDS WAS ALSO PERFORMED. BOTH RECORD REVIEWS INDICATE THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATION AND PASSED ALL FINAL ACCEPTANCE CRITERIA. ADDITIONALLY, A REVIEW OF COMPLAINT HISTORY WAS CONDUCTED AND INDICATES THAT ONE OTHER COMPLAINTS ASSOCIATED WITH THE LOT INVOLVED IN THIS EVENT HAS BEEN RECEIVED.

Description of Event or Problem

PEPGEN P-15 PUTTY WAS PLACED SIMULTANEOUSLY WITH AN IMPLANT IN THE LEFT POSTERIOR MAXILLA WITH REPORTED BONE QUALITY TYPE II. OSTEOTOMY PREPARATION APPEARS TO BE VIA BONE CONDENSING SOLELY; BONE CONDENSING IS GENERALLY LIMITED TO TYPE IV BONE. HEALING WAS TRANSGINGIVAL WITH A PROVISIONAL RESTORATION. THE IMPLANT DID NOT OSSEOINTEGRATE AND HAD CLINICAL MOBILITY PRIOR TO EXPLANTATION, WHICH OCCURRED APPROX SIX 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 COMPLETE INTEGRATION. HOWEVER, INTEGRATION MAY HAVE BEEN IN PROGRESS AS THE DOCTOR STATES "THE IMPLANT WAS REPLACED AT TIME OF EXPLANTATION AND WAS SUCCESSFUL," THOUGH ADD'L GRAFTING IS NOT MENTIONED. IT IS ALSO NOT CLEAR WHY GRAFTING WAS PERFORMED (I.E. BONY DEHISCENCE, IMMEDIATE PLACEMENT, PERI-IMPLANT GAP SUBSEQUENT TO BONE EXPANSION, SINUS AUGMENTATION).