OPTIMESH
Received Oct 1, 2025 · Event occurred Sep 2, 2025
Report 2135156-2025-00007 · MDR key 23194266
Device
Generic name
Intervertebral Body Graft Containment
Manufacturer
Spineology Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- 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 OPTIMESH DEVICES AT THREE CONTIGUOUS LEVELS IN THE LUMBAR SPINE WITHOUT INCIDENT. APPROXIMATELY SIX (6) MONTHS LATER, IMAGING SHOWED SOME LOSS OF DISC HEIGHT AT TWO OF THE THREE LEVELS. APPROXIMATELY TWO (2) YEARS LATER, THE PATIENT RETURNED WITH SYMPTOMS AND IMAGING SHOWED FURTHER LOSS OF DISC HEIGHT AT THE SAME TWO LEVELS AND POSTERIOR CONSTRUCT FAILURE. MEDICAL INTERVENTION HAS BEEN DEEMED NECESSARY. THIS REPORT APPLIES TO OPTIMESH DEVICE TWO OF TWO.