BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALCLOCK

    MDR report key: 1056608 · Received June 3, 2008

    Report

    Report Number
    3005039508-2008-00003
    Event Type
    Malfunction
    Date Received
    June 3, 2008
    Date of Event
    April 30, 2008
    Report Date
    May 8, 2008
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    HRS
    PMA / PMN Number
    K061400
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A 3.5MM SCREW WAS BEING IMPLANTED THROUGH THE TRANSLATION SLOT OF A CALCLOCK PLATE WHEN THE SCREW PASSED THROUGH THE SLOT. THIS SCREW WAS REMOVED THRU SLOT WHEN THE SURGEON ATTEMPTED TO IMPLANT A 4.0MM SCREW INTO THE TRANSLATION SLOT ONLY TO DISCOVER THAT THE 4.0MM ALSO PASSED THROUGH THE SLOT. THE SURGEON THEN USED 4.0 CANNULATED SCREW IN TRANSLATION SLOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALCLOCK FRACTURE REPAIR PLATE AND SCREW HRS ORTHOHELIX SURGICAL DESIGNS, INC. CAT-001-SR L386

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention