BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURVTEK CARTRIDGE 12MM LARGE

    MDR report key: 678867 · Received February 22, 2006

    Report

    Report Number
    2027970-2006-00002
    Event Type
    Injury
    Date Received
    February 22, 2006
    Report Date
    January 24, 2006
    Manufacturer
    ARTHROTEK, INC.
    Product Code
    GFG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CARTRIDGE FAILED TO CREATE A TUNNEL. THE SURGEON COMPLETED THE TUNNEL BY DISSECTING THE TUNNEL OUT RESULTING IN ADDITIONAL SURGERY TIME. NO PT INJURY REPORTED BY USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURVTEK CARTRIDGE 12MM LARGE GFG GFG ARTHROTEK, INC. * 387040

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention