BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HINTERMANN SERIES H2 POLY ASSEMBLY

    MDR report key: 9419291 · Received December 5, 2019

    Report

    Report Number
    3012104767-2019-00003
    Event Type
    Injury
    Date Received
    December 5, 2019
    Date of Event
    November 5, 2019
    Report Date
    December 6, 2019
    Manufacturer
    DT MEDTECH, LLC
    Product Code
    HSN
    UDI-DI
    00+B0953213051
    PMA / PMN Number
    K171004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY ON ASYMPTOMATIC PATIENT AT 6 WEEKS POST-OP BASED ON XRAY RESULTS INDICATING MOVEMENT/MALALIGNMENT OF ANKLE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1214882 HINTERMANN SERIES H2 POLY ASSEMBLY ANKLE, POLY COMPONENT HSN DT MEDTECH, LLC 321305 AAAER 00+B0953213051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other