BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1000295 · Received February 14, 2008

    Report

    Report Number
    2242816-2008-00011
    Event Type
    Malfunction
    Date Received
    February 14, 2008
    Date of Event
    August 6, 2007
    Report Date
    January 30, 2008
    Manufacturer
    EBI
    Product Code
    KWQ
    PMA / PMN Number
    K060379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE SUPERIOR SCREW OF A 3 LEVEL CONSTRUCT HAS FRACTURED, AND THE OTHER SUPERIOR SCREW HAS BACKED OUT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1