BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 2112468 · Received June 3, 2011

    Report

    Report Number
    1030489-2011-00663
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Report Date
    May 6, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 AT SOME POINT POST-OP THE ZEPHIR SCREW BACKED OUT OF THE ZEPHIR PLATE. NO REVISION SURGERY HAS BEEN SCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM KWP MEDTRONIC SOFAMOR DANEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1