InjuryGAD
BODY ASSEMBLY
Received May 18, 2026 · Event occurred Apr 22, 2026
Report 0001822565-2026-01601 · MDR key 25199677
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Nerve Damage
Narrative
Additional Manufacturer Narrative
(B)(4). G2: FOREIGN - EVENT OCCURRED IN JAPAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT DURING THE PROCEDURE, THE RETRACTOR WAS INSERTED TOO DEEPLY, RESULTING IN SCIATIC NERVE PARALYSIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.