MESH 22X28 OVAL 50MM HEIGHT
Received Aug 18, 2009
Report 1526439-2009-00126 · MDR key 1444513
Device
Generic name
Vba Implant
Manufacturer
Depuy Spine, Inc.Model number
NACatalog number
174151000
Lot number
V94SD4
Product problems
- Device Issue
Patient
UNK
- Surgical procedure, repeated
Narrative
Description of Event or Problem
IN 2004, T10-L2 INSTRUMENTATION WAS DONE FOR THE PT WITH BONE TUMORS OF THE SPINE. THE MESH WAS INSERTED T12. IN 2007, THE DAMAGE OF THE MESH WAS CONFIRMED IN X-RAY. AFTER THAT, BOTH OF THE POSTERIOR RODS WERE DAMAGED. A REVISION PROCEDURE WAS PERFORMED. ACCORDING TO THE DOCTOR, L1 WAS WEDGE-SHAPED AND THE MESH COULD NOT BE PLACED THERE PROPERLY. THE DOCTOR THOUGHT THAT MADE THE IMPLANTS BROKEN.
Additional Manufacturer Narrative
NO CONCLUSIONS CAN BE MADE AT THIS TIME. BASED ON THE DESCRIPTION OF THE EVENT, IT APPEARS THAT PT ANATOMY MAY HAVE CONTRIBUTED TO THIS EVENT.