BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURVTEK CARTRIDGE 12MM LARGE

    MDR report key: 671330 · Received January 31, 2006

    Report

    Report Number
    2027970-2006-00001
    Event Type
    Injury
    Date Received
    January 31, 2006
    Report Date
    January 12, 2006
    Manufacturer
    ARTHROTEK, INC.
    Product Code
    GFG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEVICE DRILL TIP FRACTURED DURING USE. BROKEN PIECE HAD TO BE EXTRACTED CAUSING ADDITIONAL SURGERY TIME. NO PATIENT INJURY REPORTED BY USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURVTEK CARTRIDGE 12MM LARGE GFG GFG ARTHROTEK, INC. * 974180

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention