inforMED
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.