InjuryEZK
PYRAMESH
Received Sep 8, 1998 · Event occurred Aug 11, 1998
Report 1030489-1998-00070 · MDR key 186129
Device
Generic name
Mesh, Metal
Manufacturer
Sofamor Danek Mfg.Model number
NACatalog number
905-161
Lot number
UNK
Product problems
- Break
- Explanted
- Replace
Patient
51 YR
- Pain
- Surgical procedure, repeated
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
THE DEVICE WAS IMPLANTED ON 06/09/1998. X-RAYS WERE TAKEN DUE TO COMPLAINTS OF PAIN. X-RAYS REVEALED THAT A SECTION OF THE DEVICE WAS BROKEN. REVISION SURGERY WAS PERFORMED ON 08/11/98 TO REMOVE AND REPLACE THE DEVICE. IT WAS REPORTED THAT THE DEVICE WAS BROKEN AND DEFORMED. IT IS UNKNOWN AT WHAT TIME THE FRACTURE AND DEFORMATION OCCURRED.