InjuryJDN
IMPLANT, FIXATION DEVICE, SPINAL
Received Aug 12, 2023
Report MW5139985 · MDR key 17533079
Device
Generic name
Implant, Fixation Device, Spinal
Manufacturer
UnknownProduct problems
- Therapeutic or Diagnostic Output Failure
- Therapeutic or Diagnostic Output Failure
Patient
Unknown
- Pain
- Pain
Narrative
Description of Event or Problem
THE PATIENT REPORTED THAT THEY HAD HARDWARE IN THEIR BACK THAT WAS NOT WORKING. THE PATIENT ALSO REPORTED THEIR PAIN HAD PROGRESSED AND WAS CONSIDERABLY WORSE. (B)(6). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).