OSTEOPLUG

Additional Manufacturer Narrative

THIS COMPLAINT WAS REPORTED OUTSIDE OF THE US MARKET. THIS DEVICE MODEL NUMBER IS NOT MARKETED IN THE US MARKET. HOWEVER, THE DEVICE IS SIMILAR IN MATERIAL AND MANUFACTURING PROCESS TO DEVICES CLEARED TO BE MARKETED IN US. THE INTERNAL INVESTIGATION INTO DEVICE PRODUCTION LOT INCLUDED A REVIEW OF THE REPORTED INFORMATION, REVIEW OF THE DEVICE HISTORY AND COMPLAINT HISTORY RECORDS. 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. 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.

Description of Event or Problem

DEVICE IMPLANTED ON (B)(6) 2023. ON (B)(6) 2023, IT WAS REPORTED THAT THE PATIENT HAD PUS. INFORMATION FROM SURGEON ON (B)(6) 2023: 1. PUS WAS FOUND AT THE SKIN WOUND. 2. IMPLANT SENT FOR CULTURE. 3. WOUND WAS RE-OPENED FOR WASHOUT. 4. ANTIBIOTICS ADMINISTERED AND COMPLETED. PATIENT IS REPORTED TO BE IN STABLE CONDITION NOW. IT WAS REPORTED ON (B)(6) 2023 THAT TEST ON CULTURE SHOWED PRESENCE OF STAPHYLOCOCCUS AUREUS.