OtherMBP
AFT
Received Aug 1, 2007 · Event occurred Jul 1, 2007
Report 2249062-2007-00009 · MDR key 888419
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
52 YR
- Bacterial Infection
- Surgical procedure
- Inadequate Pain Relief
Narrative
Description of Event or Problem
THE PATIENT FELL IN 2007 AND SUSTAINED ACUTE AND PAINFUL L2 AND L3 FRACTURES. THE NEXT MONTH, SHE WAS TREATED AT 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. ONE MONTH LATER, THE PATIENT UNDERWENT A REVISION SURGERY DURING WHICH BOTH IMPLANTS AND THE BONE GRAFT WERE REMOVED.