InjuryJDN
IMPLANT, FIXATION DEVICE, SPINAL
Received Aug 12, 2023
Report MW5137049 · MDR key 17530128
Device
Generic name
Implant, Fixation Device, Spinal
Manufacturer
UnknownProduct problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Abscess
- Unspecified Infection
- Abscess
- Unspecified Infection
Narrative
Description of Event or Problem
THE PATIENT REPORTED THEY HAD SURGERY TO REMOVE THE SCREWS AND RODS IN THEIR BACK, AND THAT THEY HAD A MASSIVE INFECTION AND ABSCESS IN THEIR SPINE AFTER THE REMOVAL. THE PATIENT ALSO REPORTED THEY WERE IN AND OUT OF THE HOSPITAL 3-4 TIMES. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).