BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALCLOCK

    MDR report key: 3008491 · Received October 2, 2008

    Report

    Report Number
    3005039508-2008-00006
    Event Type
    Malfunction
    Date Received
    October 2, 2008
    Date of Event
    August 21, 2008
    Report Date
    September 3, 2008
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    KTT
    PMA / PMN Number
    K061400
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN APPLYING A CALCLOCK PLATE, THE FIRST SCREW, A 3.5 NON-LOCKING SCREW PASSED THROUGH THE TRANSLATION SLOT. THE SCREW WAS TIGHTENED IN ORDER TO CONTOUR THE PLATE DOWN TO THE BONE WHEN THE SCREW HEAD THEN WENT THROUGH THE SLOT. THE SCREW WAS REMOVED. THE SURGEON PROCEEDED TO FIX THE PLATE TO THE BONE BY USING OTHER PLATE HOLES AND SCREWS AND THEN REPLACED THE SLOT SCREW WITH A 4.0 SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALCLOCK FRACTURE REPAIR PLATE AND SCREW KTT ORTHOHELIX SURGICAL DESIGNS, INC. CAT-001-LR L217

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention