BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMESH

    MDR report key: 9959206 · Received April 14, 2020

    Report

    Report Number
    2135156-2020-00002
    Event Type
    Malfunction
    Date Received
    April 14, 2020
    Date of Event
    March 7, 2020
    Report Date
    April 14, 2020
    Manufacturer
    SPINEOLOGY, INC.
    Product Code
    EZX
    UDI-DI
    M74033020050
    PMA / PMN Number
    K014200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE ADVERSE EVENT COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    AS REPORTED BY THE SURGEON: THE PATIENT UNDERWENT AN INTERBODY FUSION PROCEDURE WITH PLACEMENT OF AN OPTIMESH DEVICE WITH BONE GRAFT ON (B)(6) 2020 WITHOUT INCIDENT. THE PATIENT COMPLAINED OF PAIN AND A CT SCAN SHOWED BONE GRAFT IN THE CENTRAL CANAL AND EXITING FORAMEN. THE SURGEON OPTED TO REOPERATE ON (B)(6) 2020. DURING THE REOPERATION THE BONE GRAFT WAS EASILY REMOVED WITH SUCTION AND THE OPTIMESH DEVICE WAS EASILY REMOVED FROM THE DISC SPACE WITH A PITUITARY RONGEUR. A DIFFERENT INTERBODY FUSION DEVICE WAS IMPLANTED AND THE REOPERATION WAS COMPLETED AS INTENDED AND WITHOUT PATIENT CONSEQUENCE. THE SURGEON REPORTED ON (B)(6) 2020 THAT THE PATIENT'S SYMPTOMS CAUSED BY THE GRAFT IN THE CANAL WERE GONE AND THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420725 OPTIMESH MESH, GRAFT CONTAINMENT EZX SPINEOLOGY, INC. S16634 M74033020050

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other