BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUNTER TENDON ROD

    MDR report key: 1199960 · Received October 16, 2008

    Report

    Report Number
    1043534-2008-00303
    Event Type
    Injury
    Date Received
    October 16, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 16, 2008
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HXA
    PMA / PMN Number
    K8534389
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. PRODUCT WAS NOT RETURNED FOR EVALUATION. DEVICE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, A MEDWATCH 3500A HAS NOT BEEN RECEIVED FROM THE USER FACILITY. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ALLEGEDLY ROD WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUNTER TENDON ROD HXA WRIGHT MEDICAL TECHNOLOGY, INC. NA 05483969

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| R