CD HORIZON SPINAL SYSTEM
Received Jan 28, 2009 · Event occurred Oct 27, 2008
Report 1030489-2009-00085 · MDR key 1342503
Device
Product problems
- Implant breakage or physical damage
Patient
20 YR
- Pain
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT SURGERY FOR IMPLANT OF POSTERIOR HARDWARE. IT WAS REPORTED THAT THE PATIENT RETURNED TO THE HOSPITAL COMPLAINING OF BACK DISCOMFORT. A REVISION SURGERY IS PLANNED BUT HAS NOT BEEN REPORTED.
Additional Manufacturer Narrative
(B)(4). THE DEVICES HAVE NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION. X-RAY IMAGES WERE RETURNED FOR EVALUATION. AP AND LATERAL IMAGES TAKEN ON (B)(6) 2008 SHOW CONSTRUCT AT T11-L3 FOR A FRACTURE OF L1. PEDICLE SCREWS IN L3 HAVE FRACTURED MID PEDICLE. UNABLE TO DETERMINE CAUSE OF THE EVENT.
Additional Manufacturer Narrative
CORRECTED/ADDITIONAL INFORMATION.
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT'S ATTORNEY STATES THAT THE PATIENT UNDERWENT ADDITIONAL SURGERY DUE TO THE HARDWARE FAILURE.