OPTIMESH
Received Aug 25, 2009 · Event occurred Jun 25, 2009
Report 2135156-2009-00004 · MDR key 1456897
Device
Generic name
Surgical Mesh Ezx
Manufacturer
Spineology, Inc.Model number
OPTIMESH 1500Catalog number
550-2505
Lot number
S08009
Product problems
- Improper or Incorrect Procedure or Method
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
PHYSICIAN IMPERFECTLY PLACED AN OPTIMESH DEVICE IN THE L4 VERTEBRAL BODY IN A PT WITH A PREVIOUS L4-L5 INTERBODY INFUSION (INCLUDING PEDICLE SCREWS FROM A DIFFERENT MANUFACTURER). UPON RE-INJURY, THE PT DEVELOPED RADICULAR PAIN AND NUMBNESS. ONE OF THE PEDICLE SCREWS AT L4 HAD PULLED OUT AND THE VERTEBRAL BODY PARTIALLY COLLAPSED. MRI SHOWED THAT THE SPINAL CANAL WAS 50% COMPROMISED AT L4. LOOSE BONE FRAGMENTS IN THE CANAL WERE NOTED. PT UNDERWENT REVISION SURGERY AND THE OPTIMESH DEVICE WAS CUT BY THE SURGEON CONTRARY TO RECOMMENDATION. THE REVISION SURGERY WAS SUCCESSFUL.