BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINEOLOGY OPTIMESH TRAY

    MDR report key: 3603245 · Received January 29, 2014

    Report

    Report Number
    MW5034122
    Event Type
    Injury
    Date Received
    January 29, 2014
    Date of Event
    January 9, 2014
    Report Date
    January 24, 2014
    Manufacturer
    SPINEOLOGY, INC.
    Product Code
    GZX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SET-UP IN OPERATING ROOM FOR A MINIMALLY INVASIVE SPINE PROCEDURE, DEBRIS WAS FOUND ON OPERATING ROOM TABLE. DEBRIS CAME OUT OF AN INSTRUMENT FROM A VENDOR LOANED SET. ROOM WAS CLEANED. NEW SUPPLIES AND INSTRUMENTATION WAS OBTAINED. THE THREE PIECES OF EQUIPMENT WERE REMOVED FROM SERVICE AND RETURNED TO VENDOR SINCE IT WAS LOANED EQUIPMENT. ANOTHER TRAY WAS SET UP FOR THE CASE THAT DID NOT HAVE ANY VISIBLE DEBRIS. AS PART OF INVESTIGATION, A STERILE TRAY WAS EXAMINED AND DEBRIS WAS FOUND AFTER MANIPULATING THE EQUIPMENT. THIS MAY BE A PROBLEM WITH THE DESIGN OF THE EQUIPMENT THAT WILL NOT ALLOW YOU TO TAKE IT APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62478 SPINEOLOGY OPTIMESH TRAY INSERTER ARTICULATING CURETTE GZX SPINEOLOGY, INC. 3110100
    62479 SPINEOLOGY OPTIMESH TRAY ELOCKING MESH HOLDER GZX SPINEOLOGY, INC. 311088
    62480 SPINEOLOGY OPTIMESH TRAY 6.5MM SHAPER GZX SPINEOLOGY, INC. 3110042

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention