BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSURE TOP

    MDR report key: 4294625 · Received November 25, 2014

    Report

    Report Number
    2184052-2014-00190
    Event Type
    Injury
    Date Received
    November 25, 2014
    Report Date
    October 31, 2014
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    KWP
    PMA / PMN Number
    K133556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    SAME CASE AS: 2184052-2014-00192 AND 2184052-2014-00193. IT WAS REPORTED THAT 2 VIRAGE CLOSURE TOPS BACKED OUT POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED (B)(6) 2014. DURING THE REVISION SURGERY A DIFFERENT VIRAGE CLOSURE TOP WAS DISCOVERED TO BE LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766447 CLOSURE TOP CLOSURE TOP KWP ZIMMER SPINE, INC. 07.01728.001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention