OPTIMESH
Received Dec 22, 2025 · Event occurred Jun 3, 2025
Report 2135156-2025-00012 · MDR key 23873094
Device
Generic name
Intervertebral Body Graft Containment
Manufacturer
Spineology Inc.Catalog number
300-3032
Lot number
S27035
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
46 YR · Female
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE INFORMATION CONTAINED IN THIS REPORT IS BEING PROVIDED TO THE FDA TO COMPLY WITH MEDICAL DEVICE REPORTING REGULATIONS AND IS BASED ON INFORMATION SUBMITTED BY OTHERS THAT MAY NOT BE FACTUALLY CORRECT. THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OF ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR THAT A DEVICE IS RELATED TO AN INJURY OR DEATH. PURSUANT TO MANUFACTURER POLICY, EVENTS RESULTING IN A REVISION SURGERY ARE DEEMED A SERIOUS INJURY AS DEFINED IN 21 CFR 803.3 AND ARE DETERMINED TO BE MDR REPORTABLE EVENTS.
Description of Event or Problem
THE PATIENT UNDERWENT AN INTERBODY FUSION PROCEDURE WITH PLACEMENT OF AN OPTIMESH DEVICE. POST-OPERATIVE, A REVISION SURGERY WAS DEEMED NECESSARY TO REMOVE AND REPLACE THE IMPLANT.