BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZADEVLIT

    MDR report key: 279286 · Received May 24, 2000

    Report

    Report Number
    MW1018986
    Event Type
    Malfunction
    Date Received
    May 24, 2000
    Date of Event
    February 28, 2000
    Report Date
    May 18, 2000
    Manufacturer
    DANEK MEDICAL, INC.
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH A T10 LESION UNDERWENT A T8-T10 ARTHRODESIS, T10 CORPECTOMY, T8-9 DISKECTOMY AND Z PLATE WITH HUMERUS ALLOGRAFT. A 70 MM ZADEVLIT PLATE WAS ORIGINALLY INTENDED TO BE USED; HOWEVER, THE Z PLATE WAS MISSING ITS WASHER, WHICH CAUSED THE T9 BOLT TO LOOSEN AND REQUIRED THE SURGEON TO EXTEND THE FUSION SUPERIORLY USING A LARGER, 90 MM PLATE. THERE WAS NO SEQUELA TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZADEVLIT 70 MM FUSION PLATE KWQ DANEK MEDICAL, INC. DK DK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other