inforMED
MalfunctionEZX

OPTIMESH

Received Oct 28, 2018 · Event occurred Oct 3, 2018

Report 2135156-2018-00009 · MDR key 8012455

Device

Generic name

Surgical Mesh

Manufacturer

Spineology Inc.

Catalog number

330-2705

Lot number

S17779

Product problems

  • Appropriate Device Problem Term/Code Not Available

Patient

67 YR

  • Pain
  • Pain

Narrative

Description of Event or Problem

PATIENT AWOKE WITH NEW LEG PAIN FOLLOWING LUMBAR FUSION SURGERY. A FOLLOW-UP CT IDENTIFIED BONE GRAFT IN THE CENTRAL CANAL AT L3-L4. A SECOND SURGERY WAS PERFORMED TWO DAYS LATER. A LAMINECTOMY WAS PERFORMED AT L2-L3 AND BONE GRAFT WAS REMOVED FROM THE CANAL AT L2-L3 AND AT L3-L4, AND INTRAOPERATIVE NEUROMONITORING SHOWED IMMEDIATE IMPROVEMENT. THE IMPLANT AND A LARGE PIECE OF DISC MATERIAL WERE BOTH REMOVED FROM THE L3-L4 DISC SPACE AND REPLACED WITH AN EXPANDABLE FUSION CAGE AND ALLOGRAFT. THE SYMPTOMS ARE REPORTED TO BE RESOLVED.