BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 961549 · Received December 6, 2007

    Report

    Report Number
    2242816-2007-00067
    Event Type
    Malfunction
    Date Received
    December 6, 2007
    Date of Event
    October 25, 2007
    Report Date
    November 29, 2007
    Manufacturer
    EBI.
    Product Code
    KWQ
    PMA / PMN Number
    K060379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOW UP IMAGING OF AN ANTERIOR CERVICAL DISECTOMY AND FUSION INDICATES POSSIBLE HARDWARE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI ANTERIOR CERVICAL PLATE SYSTEM KWQ EBI. 423851

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR