BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DARCO(R) LOCKING SCREW

    MDR report key: 2905620 · Received January 9, 2013

    Report

    Report Number
    1043534-2013-00036
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    September 12, 2012
    Report Date
    April 19, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    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 DIMENSIONALLY INSPECTED AND PHOTOGRAPHIC IMAGES WERE MADE OF THE RETURNED PRODUCT.(B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2013-00036.

    Description of Event or Problem · 1

    ALLEGEDLY BROKEN SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11745 DARCO(R) LOCKING SCREW SMALL JOINT COMPONENT, CODE:HRS HRS WRIGHT MEDICAL TECHNOLOGY, INC. 06772207G0701

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention