OPTIMESH
Received Nov 12, 2025 · Event occurred Oct 17, 2025
Report 2135156-2025-00010 · MDR key 23534522
Device
Generic name
Intervertebral Body Graft Containment
Manufacturer
Spineology Inc.Catalog number
300-3032
Lot number
S26585
Product problems
- Unintended Movement
- Unintended Movement
Patient
40 YR · Female
- Pain
- Pain
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 WITHOUT INCIDENT. APPROXIMATELY ONE (1) MONTH LATER, THE PATIENT RETURNED WITH SYMPTOMS AND A REVISION SURGICAL PROCEDURE WAS CONDUCTED TO REMOVE AND REPLACE THE IMPLANT.