BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUMATCH CMF

    MDR report key: 22826116 · Received August 18, 2025

    Report

    Report Number
    3005718816-2025-00005
    Event Type
    Malfunction
    Date Received
    August 18, 2025
    Date of Event
    July 21, 2025
    Report Date
    August 18, 2025
    Manufacturer
    MATERIALISE NV
    Product Code
    HWT
    PMA / PMN Number
    E442929
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ONGOING; RC UNKNOWN.

    Description of Event or Problem · 0

    THE INTERMEDIATE SPLINT WAS PLACED IN THE PATIENT AFTER THE MANDIBLE WAS CUT. HOWEVER, THE MANDIBLE WAS NOT MOVED TO PLANNED FINAL POSITION.

    Description of Event or Problem · 0

    THE INTERMEDIATE SPLINT DID NOT BRING THE MANDIBLE INTO PLANNED OCCLUSION. REVISION SURGERY WILL BE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1762472 TRUMATCH CMF PATIENT SPECIFIC SPLINT, ORTHOGNATHIC, INTERMEDIATE HWT MATERIALISE NV SD900.008 MU25QANGOF

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Female Other