PEPGEN P-15 PUTTY

Description of Event or Problem

PEPGEN P-15 PUTTY WAS PLACED SIMULTANEOUSLY WITH AN IMPLANT INTO A MAXILLARY CANINE EXTRACTION SOCKET. THE DOCTOR STATES AT FOUR MONTHS POST-OP, THAT HE "COULD SEE THE IMPLANT THREADS THROUGH THE TISSUE" AND, THAT HE BELIEVES THE PATIENT'S BONE WAS TOO THIN IN SOME AREAS. AS A RESULT, THE IMPLANT WAS EXPLANTED AND THE SITE REGRAFTED AND LEFT TO HEAL BEFORE PLACING ANOTHER IMPLANT.

Additional Manufacturer Narrative

FURTHER ATTEMPTS TO GATHER ADDITIONAL INFORMATION PROVED UNSUCCESSFUL. THUS, THE PATIENT'S DENTAL AND MEDICAL HISTORY IS UNK AS WELL AS ANY SIGNS OF INFLAMMATION, INFECTION, IMPLANT MOBILITY, GRAFT SLOUGHING, SPECIFICS OF GRAFT SITE, ETC. FURTHERMORE, IT IS NOT CLEAR IF THE GRAFT INTEGRATED WITH THE SURROUNDING VITAL BONE OR IF IT ALSO FAILED WITH THE IMPLANT. FAILURE TO OSSEOINTEGRATE, WHILE UNCOMMON, IS AN INHERIT 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 (WHICH IS UNK), 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 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 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.