BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAK/VISTA

    MDR report key: 1731674 · Received June 9, 2010

    Report

    Report Number
    2184052-2010-00011
    Event Type
    Malfunction
    Date Received
    June 9, 2010
    Date of Event
    May 12, 2010
    Report Date
    May 12, 2010
    Manufacturer
    ZIMMER SPINE
    Product Code
    MAX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEWED DEVICE HISTORY RECORDS. DEVICE MANUFACTURED TO ALL APPLICABLE SPECIFICATIONS.

    Description of Event or Problem · 1

    AT THE PATIENT'S ONE MONTH FOLLOW UP, THE SURGEON OBSERVED THE CAGE HAD MIGRATED POSTERIORLY. THE PATIENT IS ASYMPTOMATIC AT THIS TIME. DEVICE REMAINS IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAK/VISTA 11X12MM CAGE MAX ZIMMER SPINE 07.00201.002 60941651

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other