BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEDENT

    MDR report key: 21872968 · Received April 21, 2025

    Report

    Report Number
    3016074824-2025-00032
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Date of Event
    March 27, 2025
    Report Date
    April 21, 2025
    Manufacturer
    STRATASYS LTD.
    Product Code
    EBI
    PMA / PMN Number
    K220771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT'S DENTURE BROKE DOWN THE MIDDLE DURING INSERT - NO KNOWN DAMAGE OR ILL EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014851 TRUEDENT TRUEDENT EBI STRATASYS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown