BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARCO(R) LOCKING SCREW

    MDR report key: 1960535 · Received January 13, 2011

    Report

    Report Number
    1043534-2011-00008
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 14, 2010
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HRS
    PMA / PMN Number
    K061808
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN.VISUALLY EXAMINED. PHOTOGRAPHIC IMAGES MADE. COMPLAINT REVIEWED AND ANALYSIS SHOWED NO TREND. DEVICE HISTORY RECORD REVIEWED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT DEVICE CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B)(4).

    Description of Event or Problem · 1

    ALLEGEDLY THE SCREWS BROKE IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DARCO(R) LOCKING SCREW SMALL JOINT COMPONENT HRS WRIGHT MEDICAL TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR