BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EBI ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1031221 · Received April 14, 2008

    Report

    Report Number
    2242816-2008-00051
    Event Type
    Injury
    Date Received
    April 14, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 3, 2008
    Manufacturer
    EBI
    Product Code
    KWQ
    PMA / PMN Number
    K060379
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PN 5001601, LOT #W12205/1; PN 5001514 LOT # 008841, 010724. MFG DATES: 03/2007, 11/2006.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL GUIDE ATTACHED TO THE CERVICAL PLATE AS INTENDED. A DRILL BIT WAS THEN PASSED THROUGH THE GUIDE AND PLATE AND DRILLED A HOLE INTO THE VERTEBRAL BODY AS INTENDED. IT WAS THEN REPORTED THAT THE DRILL BIT WOULD NOT BACK OUT OF THE DRILL GUIDE AND THAT THE DRILL GUIDE WOULD NOT UN-THREAD FROM THE CERVICAL PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI ANTERIOR CERVICAL PLATE SYSTEM KWQ EBI 321944

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention