METHOD: RTI/TMI CONDUCTED A RE-REVIEW OF THE PRODUCT HISTORY FOR COPIOS PERICARDIUM MEMBRANES, PACKAGING PRODUCTION RECORDS, DISTRIBUTION FOR RELATED COMPLAINTS ASSOCIATED TO THE LOT. RESULTS: THERE WAS ONE DEPARTURE NOTED DURING RECORDS REVIEW FOR THE RELATED STERILIZATION BATCH THE BIOBURDEN ACTION LIMIT FOR THE NACL SOLUTION WAS EXCEEDED. AT THAT TIME, TISSUE SAMPLES WERE OBTAINED FOR ALL AFFECTED TUTOPLAST PREPARATIONS AND BIOBURDEN WAS TESTED. ALL RESULTS MET REQUIREMENTS. RTI/TMI HAS DISTRIBUTED A TOTAL OF (B)(4) GRAFTS SPECIFIC TO COPIOS PERICARDIUM MEMBRANES WITHOUT RELATED COMPLAINTS FOR THE LOT. CONCLUSION: GIVEN THE FACTS THAT THE XENOGRAFT UNDERWENT A VALIDATED STERILIZATION METHODOLOGY; TUTOPLAST?, WHICH INCLUDES TERMINAL STERILIZATION BY GAMMA IRRADIATION AFTER FINAL PACKAGING; SERIAL ID (B)(4) MET RT/TMI'S SPECIFICATIONS AND RELEASE CRITERIA PRIOR TO DISTRIBUTION; THERE ARE NO RELATED COMPLAINTS ASSOCIATED WITH XENOGRAFTS DISTRIBUTED FROM THE LOT; AND ( THE SYMPTOMS EXPERIENCED BY THE PATIENT (SWELLING AND PAIN) ARE EXPECTED FOR THIS KIND OF SURGERY, AND NO INFECTION WAS DOCUMENTED, IT IS MORE PLAUSIBLE THE PATIENT'S SYMPTOMS WAS ASSOCIATED WITH A SOURCE OR EVENT EXTRINSIC TO THE XENOGRAFT IMPLANT. EXPLANTED NOT AVAILABLE.
D
Patient 1
ON B)(6) 2017 IT WAS REPORTED THE DENTIST IMPLANTED A COPIOS PERICARDIUM MEMBRANE AND A PUROS BLOCK (ALLOGRAFT} AND PUROS PARTICLES (ALLOGRAFT} FOR THE BONE AUGMENTATION OF A SINGLE MISSING TOOTH (LOCATION 26). ON (B)(6) VERTICAL/LATERAL BONE AUGMENTATION WAS PERFORMED; THE PERIOSTEUM WAS CUT AND THE WOUND WAS CLOSED TIGHT. ON (B)(6) 2017, SECONDARY BLEEDING WAS OBSERVED WHICH WAS FIXED WITH AN ADDITIONAL SUTURE. ON (B)(6) 2017 FAILURE OF THE PROCEDURE NOTICED BASED ON THE FACT THAT THE BONE MATERIAL WAS NOT COVERED ANY MORE BUT EXPOSED. SUBSEQUENTLY, ON (B)(6) 2017 A WOUND REVISION WAS PERFORMED AND THE GRAFT EXPLANTED. AT THE TIME OF GRAFT EXPLANTATION IT WAS NOTED THAT THE CONNECTION BETWEEN THE GRAFT AND THE PERIOSTEUM HAD A GEL-LIKE APPEARANCE. IN ADDITION, THE PATIENT SUFFERED FROM PAIN, REDNESS, INFLAMMATION, SWELLING, TISSUE AND SUTURE DEHISCENCE. THE DOCTOR FURTHER NOTED THAT THE BONE BLOCK WAS VERY CANCELLOUS WHICH MADE IT DIFFICULT TO PLACE THE SCREW. NEVERTHELESS, THE SCREW WAS PLACED AND AT TIME OF EXPLANTATION THE SCREW APPEARED TO BE WELL FIXED IN THE BONE BLOCK. MEDICATION PRIOR TO SURGERY COMPRISED OF AMOXICILLIN THE NIGHT BEFORE AND THE MORNING OF THE SURGERY. AMOXICILLIN MEDICATION WAS CONTINUED FOR 10 DAYS AND IBUPROFEN FOR AN UNDEFINED PERIOD OF TIME POST -SURGERY.