BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 4170509 · Received October 9, 2014

    Report

    Report Number
    3003640913-2014-00074
    Event Type
    Injury
    Date Received
    October 9, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO DEVIATIONS REPORTED IN THE DHR FOR PART # 400-141, LOT # 0924088. ALL PARTS WERE RELEASED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    STAR TOTAL ANKLE REPLACEMENT SLIDING CORE MOBILE BEARING WAS EXCHANGED DUE TO IMPLANT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636922 STAR TOTAL ANKLE REPLACEMENT SLIDING CORE MOBILE BEARING NTG SMALL BONE INNOVATIONS, INC. 400-141 0924088

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention