BEUDAMED
    FDA Adverse Event Death Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 2742820 · Received September 13, 2012

    Report

    Report Number
    1030489-2012-01604
    Event Type
    Death
    Date Received
    September 13, 2012
    Date of Event
    August 16, 2012
    Report Date
    August 21, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE: MONTH AND YEAR ARE VERIFIED. (B)(6). (B)(4).NEITHER THE DEVICE, NOR APPLICABLE IMAGING FILMS, WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ODONTOID SCREW PLACEMENT TO TREAT AN ODONTOID FRACTURE. IT WAS REPORTED THAT DURING SCREW PLACEMENT THE GUIDE WIRE WHICH WAS BEING USED BICORTICALLY, WAS DRIVEN INTO THE BASE OF THE BRAIN APPROXIMATELY 4 INCHES. NO COMPLICATIONS WERE NOTED DURING THE SURGERY. THE SURGERY WAS COMPLETED. IT WAS REPORTED THAT SOMETIME POSTOPERATIVELY THAT THE PATIENT WAS BRAIN DEAD AND HAD EXPIRED. THE SURGEON BELIEVES THAT THE GUIDEWIRE WAS JAMMED IN THE CANNULATED DRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT GUIDE, SURGICAL, INSTRUMENT FZX MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death SCREW, DRIVER