BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUMATCH

    MDR report key: 12382006 · Received August 30, 2021

    Report

    Report Number
    3005718816-2021-00002
    Event Type
    Injury
    Date Received
    August 30, 2021
    Date of Event
    August 5, 2021
    Report Date
    August 9, 2021
    Manufacturer
    MATERIALISE USA, LLC
    Product Code
    HWT
    UDI-DI
    05420060351167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BREAKAGE OF SPLINT RELATED TO SURGICAL PROCEDURE WITH MULTIPLE PIECE MAXILLA WITH A PALATAL SPLINT TO STABILIZE THE PIECES.

    Additional Manufacturer Narrative · 1

    INVESTIGATION ONGOING: RETURN OF DEVICE REQUESTED BUT NOT RECEIVED.

    Description of Event or Problem · 1

    PALATAL SPLINT BROKE AND COULD NOT BE USED, ADDITIONAL TREATMENT TO PLACE NEW SPLINT NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1281092 TRUMATCH PATIENT SPECIFIC SPLINT, ORTHOGNATHIC, FINAL HWT MATERIALISE USA, LLC SD900.106 MU21IKITAQ 05420060351167

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other