InjuryJBS
SPINE SYSTEM
Received Aug 12, 1996 · Event occurred Jul 10, 1996
Report 2916714-1996-00003 · MDR key 38126
Device
Product problems
- Break
- Fracture
- Implant, removal of
Patient
52 *
- Failure of Implant
- Pain
- Surgical procedure
Narrative
Description of Event or Problem
THE SURGICAL REVISION WAS COMPLETED ON 08/15/96. THE FRACTURED SCREW ON THE LEFT SIDE OF L4 AND AN UNFRACTURED SCREW ON THE RIGHT WERE EXPLANTED. BOTH SCREWS WERE REPLACED WITH 7MM SCREWS, ALONG WITH ADDITIONAL RODS AND NUTS. THE LINKING PLATES WERE PLACED FROM SIDE TO SIDE AT L5 AND L4 TO ADD ADDITIONAL STRENGTH. THE PATIENT WAS IN SATISFACTORY CONDITION POST-OP AND AT POST-OP OFFICE VISIT ON 08/28/96, PATIENT REPORTED TO BE DOING WELL.