BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUMATCH

    MDR report key: 14926836 · Received July 6, 2022

    Report

    Report Number
    3005718816-2022-00003
    Event Type
    Injury
    Date Received
    July 6, 2022
    Date of Event
    June 14, 2022
    Report Date
    June 14, 2022
    Manufacturer
    MATERIALISE USA, LLC
    Product Code
    HWT
    UDI-DI
    05420060351150
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERMEDIATE SPLINT DID NOT LEAD TO DESIRED MANDIBLE POSITION DUE TO AN ISSUE WITH THE TRANSFER OF THE PLANNING TO THE SPLINT DESIGN.

    Description of Event or Problem · 0

    INTERMEDIATE SPLINT DID NOT LEAD TO DESIRED MANDIBLE POSITION. SURGERY HAD TO BE STOPPED AND COMPLETED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376135 TRUMATCH SPLINT, ORTHOGNATHIC, INTERMEDIATE (CLEAR ACRYLIC) HWT MATERIALISE USA, LLC SD900.105 MU22AZEPEL 05420060351150

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Female Other| H