OtherMBP
AFT
Received Mar 25, 2008 · Event occurred Jul 1, 2007
Report 2249062-2008-00006 · MDR key 1023760
Device
Product problems
- Explanted
Patient
52 YR
- Bacterial Infection
- Pain
- Surgical procedure
- Therapy/non-surgical treatment, additional
Narrative
Additional Manufacturer Narrative
THIS MDR IS BEING FILED TO COMPLY WITH THE FDA'S REQUIREMENT THAT EACH MEDICAL DEVICE MUST HAVE ITS OWN MEDWATCH NUMBER.
Description of Event or Problem
THE PATIENT FELL IN 2007 AND SUSTAINED ACUTE AND PAINFUL L2 AND L3 FRACTURES. ON THE FOLLOWING MONTH, SHE WAS TREATED WITH BOTH LEVELS WITH OPTIMESH 1500E DEVICES THAT WERE FILLED WITH AFT. THE SURGERY WAS UNREMARKABLE, BUT THE SURGEON REPORTED THAT THE PATIENT NEVER GOT GOOD PAIN RELIEF. ON 07/12/2007, THE PATIENT UNDERWENT A REVISION SURGERY DURING WHICH BOTH IMPLANTS AND THE BONE GRAFT WERE REMOVED.