BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPLAN CMF

    MDR report key: 24714268 · Received March 30, 2026

    Report

    Report Number
    3003998208-2026-00006
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 3, 2026
    Report Date
    March 27, 2026
    Manufacturer
    MATERIALISE NV
    Product Code
    HWT
    UDI-DI
    05420060351150
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPLINTS DID NOT FIT, AND THE SURGERY WAS ABORTED. ADDITIONAL SURGICAL INTERVENTION IS NEEDED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775612 PROPLAN CMF PATIENT SPECIFIC SPLINT, ORTHOGNATHIC, INTERMEDIATE HWT MATERIALISE NV SD900.105 MU26QIQDOQ 05420060351150

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female Other