BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EBI ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 999229 · Received February 14, 2008

    Report

    Report Number
    2242816-2008-00012
    Event Type
    Injury
    Date Received
    February 14, 2008
    Date of Event
    January 9, 2008
    Report Date
    January 30, 2008
    Manufacturer
    EBI
    Product Code
    KWQ
    PMA / PMN Number
    K060379
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG # 5000962, LOT # 321700. CATALOG # 5000912, LOT # 502110. DATE OF MANUFACTURE: 4/2007. DATE OF MANUFACTURE: 8/2007.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 2 DISTAL SCREWS WERE STRIPPING AND WOULD NOT LOCK ONTO A1 LEVEL PLATE. NEW SCREWS AND A NEW PLATE WERE USED. THE SURGERY WAS COMPLETED AND THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI ANTERIOR CERVICAL PLATE SYSTEM KWQ EBI 837910

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention