BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUTURA CSI SUBTALAR IMPLANT DIAMETER 11

    MDR report key: 7078602 · Received December 4, 2017

    Report

    Report Number
    3004983210-2017-00029
    Event Type
    Injury
    Date Received
    December 4, 2017
    Date of Event
    June 25, 2017
    Report Date
    July 27, 2017
    Manufacturer
    TORNIER INC.
    Product Code
    MJW
    PMA / PMN Number
    K033046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW BECAME LOOSE AT 3 DAYS POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860184 FUTURA CSI SUBTALAR IMPLANT DIAMETER 11 SUBTALAR PEG IMPLANT MJW TORNIER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention