InjuryEZX
TM-500, 10X27MM; PARALLEL SLOTTED 12 MM
Received Feb 14, 2012 · Event occurred Nov 1, 2011
Report 3005751028-2012-00026 · MDR key 2460464
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Pain
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A TM-500 HAS RETROPULSED BACK INTO THE SPINAL CANAL: SURGICAL CASE ON (B)(6) 2011 AT (B)(6) WENT WELL WITH NO INDICATION OF PROBLEM OR INCIDENT. PT PRESENT TO SURGEON ((B)(6)) WEEKS LATER WITH THIGH PAIN. PT WAS IMAGED WITH MRI AND THEN TREATED WITH STEROIDS. PTS DID WELL FOR AWHILE BUT STILL HAD ISSUES. PT WAS REFERRED TO (B)(6) FOR HIS OPINION AND HE RECOMMENDED THE REMOVAL CAGE. REVISION CASE SCHEDULED FOR (B)(6) 2012 AT (B)(6) WAS CANCELLED AND RESCHEDULED FOR (B)(6) 2012 AT (B)(6).
Additional Manufacturer Narrative
INVESTIGATION IN PROCESS.