BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARCO(R) LOCKING SCREW

    MDR report key: 2451033 · Received February 14, 2012

    Report

    Report Number
    1043534-2012-00183
    Event Type
    Malfunction
    Date Received
    February 14, 2012
    Date of Event
    November 19, 2009
    Report Date
    February 27, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HRS
    PMA / PMN Number
    K061808
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A REPORTABLE MALFUNCTION. INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED AND A CONCLUSION REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. COMPLAINT HISTORY REVIEWED. ANALYSIS SHOWS NO TREND FOR ITEM.

    Description of Event or Problem · 1

    ALLEGEDLY THE HEAD STRIPED OFF WHEN THE SURGEON WAS TIGHTENING.

    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