BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEDENT

    MDR report key: 22434795 · Received July 8, 2025

    Report

    Report Number
    3016074824-2025-00034
    Event Type
    Malfunction
    Date Received
    July 8, 2025
    Date of Event
    June 30, 2025
    Report Date
    July 8, 2025
    Manufacturer
    STRATASYS LTD.
    Product Code
    EBI
    UDI-DI
    07290018915806
    PMA / PMN Number
    K220771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    POLISHED TRUEDENT DENTURES WERE SENT BY A POTENTIAL CUSTOMER FOR CYTOTOXICITY TEST AND THEY DID NOT PASS THE TEST. THE CYTO TESTS WERE PERFORMED ON THE POLISHED DENTURES THAT WERE PRINTED AND POLISHED AT STRATASYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378168 TRUEDENT TRUEDENT EBI STRATASYS LTD. 07290018915806

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown