BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 3926535 · Received July 10, 2014

    Report

    Report Number
    1030489-2014-03197
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 12, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 DURING SCREW REMOVAL THE DRIVER TIP BROKE OFF. NO FRAGMENTS WERE LEFT IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403287 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC NA BMO8K003

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREW