BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMESH

    MDR report key: 8012455 · Received October 28, 2018

    Report

    Report Number
    2135156-2018-00009
    Event Type
    Malfunction
    Date Received
    October 28, 2018
    Date of Event
    October 3, 2018
    Report Date
    October 26, 2018
    Manufacturer
    SPINEOLOGY INC.
    Product Code
    EZX
    UDI-DI
    M7403302705
    PMA / PMN Number
    K014200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT AWOKE WITH NEW LEG PAIN FOLLOWING LUMBAR FUSION SURGERY. A FOLLOW-UP CT IDENTIFIED BONE GRAFT IN THE CENTRAL CANAL AT L3-L4. A SECOND SURGERY WAS PERFORMED TWO DAYS LATER. A LAMINECTOMY WAS PERFORMED AT L2-L3 AND BONE GRAFT WAS REMOVED FROM THE CANAL AT L2-L3 AND AT L3-L4, AND INTRAOPERATIVE NEUROMONITORING SHOWED IMMEDIATE IMPROVEMENT. THE IMPLANT AND A LARGE PIECE OF DISC MATERIAL WERE BOTH REMOVED FROM THE L3-L4 DISC SPACE AND REPLACED WITH AN EXPANDABLE FUSION CAGE AND ALLOGRAFT. THE SYMPTOMS ARE REPORTED TO BE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851489 OPTIMESH SURGICAL MESH EZX SPINEOLOGY INC. S17779 M7403302705

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR