BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUNTER TENDON ROD

    MDR report key: 6093863 · Received November 10, 2016

    Report

    Report Number
    1043534-2016-00117
    Event Type
    Injury
    Date Received
    November 10, 2016
    Report Date
    November 8, 2016
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HXR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. THE INVESTIGATION IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    PER DJERBI ET AL 2016, "PROGNOSTIC FACTORS IN TWO-STAGE FLEXOR TENDON RECONSTRUCTION: IS IT POSSIBLE TO PREDICT SURGICAL FAILURE?", ONE CASE OF INFECTION OF THE SILICONE ROD IN BETWEEN THE TWO OPERATIONS WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745910 HUNTER TENDON ROD SMALL JOINT COMPONENT HXR WRIGHT MEDICAL TECHNOLOGY, INC. TRX0-0000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention