MalfunctionEZX
OPTIMESH 1500S
Received Feb 22, 2011 · Event occurred Jan 19, 2011
Report 2135156-2011-00001 · MDR key 2039206
Device
Generic name
Surgical Mesh
Manufacturer
Spineology, Inc.Model number
1500SCatalog number
UNK
Lot number
UNK
Product problems
- Malposition of Device
Patient
UNK
- Pain
Narrative
Description of Event or Problem
PT REC'D A L3-L4 FUSION APPROX 2 YEARS PRIOR TO A RECENT MOTOR VEHICLE ACCIDENT. THE PT DEVELOPED LOW BACK PAIN AFTER THE ACCIDENT AND A CT SCAN SHOWED A LARGE MASS IN THE SPINAL CANAL. THE PT WAS TAKEN TO SURGERY TO REMOVE THE MASS WHICH TURNED OUT TO BE UNCONSTRAINED BONE GRAFT AND THE OPTIMESH DEVICE. THE PREVIOUSLY INSERTED PEDICLE SCREW CONSTRUCT WAS ALSO REVISED AT THAT TIME. THE PT HAD NEW ALLOGRAFT AND A NEW PEDICLE SCREW CONSTRUCT IMPLANTED.