BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARSX

    MDR report key: 8043072 · Received November 6, 2018

    Report

    Report Number
    3007289093-2018-00026
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Date of Event
    May 11, 2018
    Report Date
    November 6, 2018
    Manufacturer
    EXTREMITY MEDICAL, LLC.
    Product Code
    HWC
    PMA / PMN Number
    K082934
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE IMPLANT BROKE AND CAUSED IRRITATION. THE IMPLANT WAS REMOVED BUT THE BROKEN FRAGMENT WAS LEFT IN PATIENT. THE JOINT WAS FUSED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884062 TARSX BONE SCREW HWC EXTREMITY MEDICAL, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention