OSTEOPLUG

Additional Manufacturer Narrative

THIS COMPLAINT WAS REPORTED OUTSIDE OF THE US MARKET. THIS DEVICE MODEL NUMBER IS MARKETED IN THE US. THE EXPLANTED DEVICE WAS NOT RETURNED TO OSTEOPORE INTERNATIONAL. A THIRD-PARTY LABORATORY ANALYSED THE HISTOLOGY SAMPLES. 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. SEARCHING OUR COMPLAINT DATABASE, THERE HAD BEEN NO OTHER COMPLAINTS REPORTED AGAINST THE SAME PRODUCTION LOT OR PART NUMBER. THE HISTOLOGY REPORT SUGGESTS THAT THE PATIENT MIGHT HAVE SUFFERED FROM A RARE CASE OF HYPERSENSITIVITY TO DEVICE MATERIAL. FROM THE REVIEW OF DEVICE LABELLING, THE RISKS RELATED TO ALLERGIES AND OTHER REACTIONS TO DEVICE MATERIAL HAD ALREADY BEEN HIGHLIGHTED. THIS APPEARS TO BE AN ISOLATED EVENT AND NO OTHER INCIDENT HAS OCCURED. 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

SURGEON REPORTED THAT PATIENT HAS AN AESTHETICALLY DISTURBING BUMP ON THE FOREHEAD. MRI SCAN (PERFORMED ON (B)(6) 2022) AND CT SCAN (DATE UNKNOWN) WERE TAKEN AND IT WAS MEDICALLY CONCLUDED THAT PATIENT WAS NOT SUFFERING FROM ANY FORM OF INFECTION. THERE WAS ALSO NO BONE FORMATION AT THE IMPLANT SITE. A SURGICAL INTERVENTION WAS PERFORMED ON (B)(6) 2022 TO REMOVE THE DEVICE. THIS COMPLAINT IS ASSOCIATED WITH THE FIRST OF 2 DEVICES IMPLANTED IN THIS PATIENT. REFER TO MEDWATCH 3007303685-2024-00005 FOR THE SECOND DEVICE IMPLANTED IN THIS PATIENT.