InjuryEZX
OPTIMESH
Received Nov 6, 2018 · Event occurred Oct 18, 2018
Report 2135156-2018-00011 · MDR key 8043440
Device
Generic name
Mesh, Graft Containment
Manufacturer
Spineology Inc.Catalog number
330-2505
Lot number
S80298
Product problems
- Stretched
- Stretched
Patient
85 YR
- Neurological Deficit/Dysfunction
- Neurological Deficit/Dysfunction
Narrative
Description of Event or Problem
DURING PLACEMENT OF THE IMPLANT AND GRAFT FOR A LUMBAR INTERBODY FUSION PROCEDURE, A PORTION OF THE DEVICE WAS FILLED INTO THE SPINAL CANAL, RESULTING IN CAUDA EQUINA SYNDROME. PATIENT WAS RETURNED TO SURGERY DUE TO POSTOPERATIVE SYMPTOMS. THE SURGEON REPORTED THAT THE DEVICE WAS FOUND INTACT BUT PROTRUDING IN THE CANAL. IT WAS REMOVED AND REPLACED WITH AN INTERBODY SPACER. PATIENT IS REPORTED TO HAVE IMPAIRED BLADDER CONTROL, LIMITED PLANTAR FLEXION AND DORSIFLEXION, AND LOWER EXTREMITY NUMBNESS WHICH IS GRADUALLY IMPROVING.