BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSURE TOP

    MDR report key: 4212969 · Received October 24, 2014

    Report

    Report Number
    2184052-2014-00186
    Event Type
    Injury
    Date Received
    October 24, 2014
    Report Date
    September 29, 2014
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    KWP
    PMA / PMN Number
    K133556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS: 2184052-2014-00188 AND 2184052-2014-00187. APPROXIMATELY ONE MONTH POST-OP THE SURGEON INDICATED THAT BOTH CLOSURE TOPS ARE BACKED OUT AT C3. ONE CLOSURE TOP APPEARS TO BE LOOSE AT C5. NO DIFFICULTIES OR UNUSUAL EVENTS WERE NOTED IN THE INITIAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678575 CLOSURE TOP CLOSURE TOP KWP ZIMMER SPINE, INC. 07.01728.001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention