BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARCO(R) LOCKING SCREW

    MDR report key: 2770509 · Received October 3, 2012

    Report

    Report Number
    1043534-2012-01264
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Report Date
    September 4, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PRODUCT WAS NOT RETURNED. (B)(4).

    Description of Event or Problem · 1

    ALLEGEDLY GERMAN SURGEON ADVISED HE HAD APPROX. 10 SCREW BREAKAGES THIS YEAR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1