BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUNTER TENDON ROD

    MDR report key: 4146767 · Received September 23, 2014

    Report

    Report Number
    1043534-2014-00153
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HXA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION NOT COMPLETE. PRODUCT HAS NOT BEEN RETURNED. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ALLEGEDLY THE IMPLANTED WAS EXPIRED, THE ISSUE WAS RESOLVED BY USING A NEW IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591028 HUNTER TENDON ROD SMALL JOINT COMPONENT HXA WRIGHT MEDICAL TECHNOLOGY, INC. 067449112

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other