OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
Received Aug 31, 2021
Report 3005031160-2021-00016 · MDR key 12403674
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
19 YR
- Damage to Ligament(s)
- Damage to Ligament(s)
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE PATIENT HAD GRAFT INCORPORATION ISSUES PRIOR TO THE IMPLANTATION OF COMPLAINT DEVICE, SUGGESTING THERE MAY HAVE BEEN SOME UNDERLYING COMORBIDITIES THAT COULD HAVE HINDERED REGENERATION OF BONE AT THE SURGICAL SITE. THE COMPLAINT DEVICE REPORTED TO HAVE INSUFFICIENT GRAFT INCORPORATION IS SUBJECT TO REGULAR OSTEOINDUCTIVITY TESTING, WHICH INDICATES BONE GROWTH POTENTIAL. THE REVISION ACL RECONSTRUCTION PROCEDURE IN WHICH THE COMPLAINT DEVICE WAS IMPLANTED WAS SUCCESSFULLY COMPLETED.
Description of Event or Problem
THE COMPANY RECEIVED NOTIFICATION ON 8/02/2021 OF A PRODUCT COMPLAINT REGARDING A COMBINATION DEVICE THAT WAS REPORTED TO NOT FUNCTION AS INTENDED FOR BONE GROWTH. IT WAS REPORTED THAT DURING A REVISION ACL RECONSTRUCTION PROCEDURE ON AN UNKNOWN DATE, THE PHYSICIAN ASSESSED THERE WAS INSUFFICIENT GRAFT INCORPORATION. THE INFORMATION PROVIDED ON THE CLINICAL COURSE OF TREATMENT WAS UNCLEAR. REPEATED ATTEMPTS FOR CLARIFICATION WERE MADE WITHOUT ANY ADDITIONAL INFORMATION PROVIDED. THE MOST RECENT REVISION ACL RECONSTRUCTION PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY KNOWN PATIENT COMPLICATIONS.