BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAK/VISTA

    MDR report key: 1464403 · Received September 3, 2009

    Report

    Report Number
    2184052-2009-00070
    Event Type
    Injury
    Date Received
    September 3, 2009
    Date of Event
    August 3, 2009
    Report Date
    August 4, 2009
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    MAX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF EVALUATION.

    Description of Event or Problem · 1

    THE ORIGINAL SURGERY OCCURRED IN 2009. THE SURGEON NOTICED THE CAGE HAD MOVED. THE CAGE WAS REMOVED IN 2009, BUT THE HARDWARE WAS LEFT IN PLACE. L5-S1 IS WHERE THE CAGE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAK/VISTA 9X24MM BAK/VISTA MAX ZIMMER SPINE, INC. 07.00202.001 60418943

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR