BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUMATCH

    MDR report key: 18284983 · Received December 7, 2023

    Report

    Report Number
    3005718816-2023-00003
    Event Type
    Injury
    Date Received
    December 7, 2023
    Date of Event
    November 3, 2023
    Report Date
    November 7, 2023
    Manufacturer
    MATERIALISE USA, LLC
    Product Code
    JEY
    UDI-DI
    05420060380143
    PMA / PMN Number
    K170272
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUDED DEVICE MET SPECIFICATIONS. THE EXACT ROOT CAUSE COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    THE SURGEON REMOVED THE TITANIUM IMPLANT FROM THE PATIENT DUE TO MALOCCLUSION AND REPLACED THE IMPLANT WITH STANDARD PLATES AND SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197498 TRUMATCH TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MIDFACE JEY MATERIALISE USA, LLC SD980.014 MU23JEFSAS 05420060380143

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Female Other