OPTIMESH
Received Sep 12, 2025 · Event occurred Aug 14, 2025
Report 2135156-2025-00005 · MDR key 23041804
Device
Generic name
Intervertebral Body Graft Containment
Manufacturer
Spineology Inc.Catalog number
300-3032
Lot number
S26010
Product problems
- Device Dislodged or Dislocated
- Device Dislodged or Dislocated
Patient
60 YR · Female
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THIS FOLLOW UP REPORT SERVES AS A CORRECTION TO THE INITIAL 30-DAY REPORT SUBMITTED ON 12-SEP-2025. SECTION H1, TYPE OF REPORTABLE EVENT, HAS BEEN CORRECTED TO INDICATE A 'MALFUNCTION' RATHER THAN A 'SERIOUS INJURY'.
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.
Description of Event or Problem
THE PATIENT UNDERWENT AN INTERBODY FUSION PROCEDURE WITH PLACEMENT OF AN OPTIMESH DEVICE WITHOUT INCIDENT. APPROXIMATELY ONE (1) YEAR LATER, THE PATIENT RETURNED WITH SYMPTOMS AND IMAGING SHOWED PARTIAL MIGRATION OF THE IMPLANT INTO THE SPINAL CANAL. MEDICAL INTERVENTION HAS BEEN DEEMED NECESSARY.