BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMESH

    MDR report key: 9923893 · Received April 3, 2020

    Report

    Report Number
    2135156-2020-00001
    Event Type
    Malfunction
    Date Received
    April 3, 2020
    Date of Event
    February 20, 2020
    Report Date
    April 3, 2020
    Manufacturer
    SPINEOLOGY, INC.
    Product Code
    EZX
    PMA / PMN Number
    K014200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE HOLE IN THE MESH COULD NOT BE DEFINITIVELY DETERMINED BUT WAS LIKELY CAUSED BY USER ERROR. THE SURGICAL TECHNIQUE WAS NOT FOLLOWED AS NO FORCE DISSIPATION METHOD WAS USED DURING THE PROCESS OF FILLING THE MESH WITH BONE GRAFT.

    Description of Event or Problem · 1

    AS REPORTED BY THE SURGEON: THE PATIENT UNDERWENT A TWO-LEVEL INTERBODY FUSION WITH PLACEMENT OF TWO OPTIMESH DEVICES 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. THE SURGEON NOTED A SMALL HOLE IN THE MESH AT THE JUNCTION OF THE NECK AND THE BODY. ANOTHER OPTIMESH DEVICE WAS IMPLANTED AND THEN FILLED WITH BONE GRAFT 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
    383065 OPTIMESH MESH, GRAFT CONTAINMENT EZX SPINEOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other