MalfunctionEZX

OPTIMESH IMPLANT

Received Aug 8, 2018 · Event occurred Jun 25, 2018

Report MW5078972 · MDR key 7768715

Device

Generic name

Mesh, Surgical, Metal

Manufacturer

Spineology, Inc.

Catalog number

330-2705

Lot number

S14252

Product problems

Material Protrusion/Extrusion

Patient

51 YR

Numbness
No Code Available
Numbness
No Code Available

Narrative

Description of Event or Problem

PT UNDERWENT MINIMALLY-INVASIVE FUSION OF L2, L3 AND L4. BONE GRAFT (BG) WAS PLACED AND POST-OP XRAYS REPORTED SHOWED BGS WITH GOOD PLACEMENT. IN RR, PT C/O BILATERAL FOOT NUMBNESS AND INABILITY TO DORSIFLEX OR PLANTAR FLEX FEET. CT SHOWED BG MATERIAL EXTRUDING FROM L4 AND L2. THE PT WAS RETURNED TO OPERATING ROOM AND SURGEON REMOVED THE BG BAGS FROM L4 AND L2. UNABLE TO GET ALL OF THE BG MATERIAL OUT.