InjuryEZX
OPTIMESH
Received Jan 31, 2017 · Event occurred Dec 31, 2016
Report 2135156-2017-00002 · MDR key 6291450
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Pain
- Pain
Narrative
Additional Manufacturer Narrative
DEVICE REMAINS IMPLANTED.
Description of Event or Problem
THE PHYSICIAN PERFORMED A 3-LEVEL LUMBAR FUSION FROM L2 TO L5 WITH PLACEMENT OF OPTIMESH AT EACH LEVEL. FOLLOWING THE SURGICAL PROCEDURE, THE PATIENT REPORTED NEUROLOGICAL SYMPTOMS. THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR EXPLORATORY SURGERY AT WHICH TIME BONE WAS IDENTIFIED NEAR NEUROLOGICAL STRUCTURES AND WAS REMOVED. FOLLOWING THE PROCEDURE, THE PATIENT'S NEUROLOGICAL SYMPTOMS WERE REPORTED TO BE RESOLVED.