OPTIMESH
Received Jul 24, 2018 · Event occurred Jun 26, 2018
Report 2135156-2018-00005 · MDR key 7716484
Device
Generic name
Graft Containment Device
Manufacturer
Spineology Inc.Catalog number
330-2505
Lot number
S80143
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.