OSTEOMESH

Description of Event or Problem

DEVICE HAD BEEN IMPLANTED FOR A PERIOD OF APPROXIMATELY 9 MONTHS BEFORE IT WAS REPORTED ON 16 OCTOBER 2023 THAT PATIENT EXPERIENCED SWELLING, SORENESS, PAIN AND FLUID ACCUMULATION. ON (B)(6) 2024, REVISION SURGERY WAS PERFORMED TO REMOVE THE DEVICE. DURING REMOVAL OF DEVICE, THE SURGEON REPORTED THAT DEVICE HAD SHOWED SIGNS OF INTEGRATION WITH SURROUNDING SOFT TISSUE. ADDITIONALLY, WITH USE OF ENDOSCOPE, A SMALL BUMP COULD BE OBSERVED IN THE RIGHT NOSTRIL, NONE OBSERVED IN THE LEFT NOSTRIL. COLOURLESS FLUID OBSERVED AFTER CUTTING INTO BUMP. NO CLEAR SIGNS INDICATING PRESENCE OF INFECTION REPORTED BY THE SURGEON. CURRENTLY, THE PATIENT IS RECOVERING WELL WITH NO MORE COMPLAINTS OF PAIN. THIS COMPLAINT IS ASSOCIATED WITH THE FIRST OF 2 DEVICES IMPLANTED IN THIS PATIENT. REFER TO MEDWATCH 3007303685-2024-00002 FOR THE SECOND DEVICE IMPLANTED IN THIS PATIENT.

Additional Manufacturer Narrative

THIS COMPLAINT WAS REPORTED OUTSIDE OF THE US MARKET. THIS DEVICE MODEL NUMBER IS NOT MARKETED IN THE US. HOWEVER, THE DEVICE IS SIMILAR IN MATERIAL AND MANUFACTURING PROCESS TO DEVICES CLEARED TO BE MARKETED IN US. THE DEVICE WAS EXPLANTED ON (B)(6) 2023 AND RETURNED TO OSTEOPORE INTERNATIONAL FOR PATHOLOGY EVALUATION. THE INTERNAL INVESTIGATION INTO DEVICE PRODUCTION LOT INCLUDED A REVIEW OF THE REPORTED INFORMATION, REVIEW OF THE DEVICE HISTORY AND COMPLAINT HISTORY RECORDS, AND ANALYSIS OF THE RETURNED BIOPSY SPECIMENS. REVIEW OF DEVICE HISTORY RECORD(S) SHOWED NO ISSUES DURING THE MANUFACTURE OF THIS DEVICE. NO NON-CONFORMITY WAS IDENTIFIED IN THE REVIEW OF THE FOLLOWING RECORDS: PRODUCTION RECORD, STERILIZATION RECORD, CERTIFICATION OF IRRADIATION. HISTOLOGICAL INVESTIGATION DID NOT REVEAL ANY FEATURES OF IMPLANT REJECTION AND, ALTHOUGH NO BACTERIA WERE OBSERVED, AN INFECTIVE AETIOLOGY MAY HAVE BEEN POSSIBLE. IN OUR INVESTIGATIONS, THERE HAD BEEN NO OTHER COMPLAINTS REPORTED AGAINST THE SAME PRODUCTION LOT. ADDITIONALLY, REVIEW OF COMPLAINT HISTORY RECORDS FROM YEAR 2020 REVEALED NO OTHER COMPLAINTS REPORTED AGAINST SIMILAR DEVICE MODEL NUMBER. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.