OPTIMESH
Received Oct 24, 2025 · Event occurred Sep 24, 2025
Report 2135156-2025-00009 · MDR key 23385569
Device
Generic name
Intervertebral Body Graft Containment
Manufacturer
Spineology Inc.Catalog number
300-2628
Lot number
S24404
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
56 YR · Male
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
THE PATIENT UNDERWENT AN INTERBODY FUSION PROCEDURE WITH PLACEMENT OF AN OPTIMESH DEVICE WITHOUT INCIDENT. APPROXIMATELY TWO (2) YEARS LATER, IMAGING SHOWED A LACK OF IMPLANT FUSION. A REVISION SURGERY WAS CONDUCTED TO REMOVE AND REPLACE THE IMPLANT.
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.