inforMED
InjuryEZX

OPTIMESH

Received Jul 24, 2018 · Event occurred Jun 26, 2018

Report 2135156-2018-00006 · MDR key 7716285

Device

Generic name

Graft Containment Device

Manufacturer

Spineology Inc.

Catalog number

330-2705

Lot number

S14252

Product problems

  • Migration
  • Migration

Patient

Not reported

  • Numbness
  • Numbness

Narrative

Description of Event or Problem

PATIENT UNDERWENT AN INSTRUMENTED 3-LEVEL LUMBAR INTERBODY FUSION PROCEDURE AT L2-3, L3-4 AND L4-5. PATIENT AWOKE POST-OP WITH BILATERAL NUMBNESS IN LOWER EXTREMITIES. IMMEDIATE CT SHOWED MIGRATION OF GRAFT/IMPLANT AT L2-3 AND L4-5, WITH ALLOGRAFT BONE IN CENTRAL CANAL. IT WAS NOTED THAT ROD REDUCTION CAUSED STRAIGHTENING OF THE CURVED RODS, INDICATING SIGNIFICANT MECHANICAL FORCE HAD BEEN APPLIED. PATIENT WAS RETURNED TO THE OR FOR DECOMPRESSION OF THE CENTRAL CANAL AND REMOVAL OF INTERBODY IMPLANTS AT L2-3 AND L4-5. ALLOGRAFT BONE WAS PLACED IN THE DISC SPACES AT THOSE LEVELS AND ADDITIONAL DORSAL GRAFTING WAS PERFORMED. PATIENT WAS DISCHARGED ON POD #5 WITH RESIDUAL NUMBNESS IN BOTH LOWER EXTREMITIES AND IS RECEIVING PHYSICAL THERAPY. NUMBNESS IS REPORTED TO BE IMPROVING.