BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANT-CER 2 LVL PLATE ASSY, 44MM

    MDR report key: 1040025 · Received May 7, 2008

    Report

    Report Number
    1649384-2008-00247
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 8, 2008
    Report Date
    May 7, 2008
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS PENDING UPON THE RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    DURING INSERTION OF THE PLATE THE DOCTOR NOTICED AFTER IMPLANTATION THAT THE RATCHETING MECHANISM WAS BEYOND LIMITATIONS. THE SCREWS WERE IN PLACE, BUT NOT COMPLETELY TIGHTENED DOWN WHEN THE SURGEON REMOVED THE CHICKLET. WHEN THE CHICKELET WAS REMOVED AND THE PLATE DISENGAGED. THE SALES REP INDICATED IT LOOKED LIKE A PIECE WAS MISSING FROM THE PLATE. THE SURGEON EXPLANTED THE PLATE AND REPLACED WITH ANOTHER. THERE WAS NO REPORT OF INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANT-CER 2 LVL PLATE ASSY, 44MM ANT-CER KWQ

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention