BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1123683 · Received August 20, 2008

    Report

    Report Number
    2242816-2008-00122
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    May 20, 2008
    Report Date
    August 19, 2008
    Manufacturer
    EBI, L.P.
    Product Code
    KWQ
    PMA / PMN Number
    K060379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOTH SCREWS HAVE BACKED OUT AT C7 FROM A C5-7 CONSTRUCT WITH GRAFT. IT WAS REPORTED THAT THE PATIENT HAS TOLERABLE SYMPTOMS. THE SCREWS REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ EBI, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1