BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEDENT

    MDR report key: 21615317 · Received March 16, 2025

    Report

    Report Number
    3016074824-2025-00013
    Event Type
    Malfunction
    Date Received
    March 16, 2025
    Date of Event
    January 3, 2024
    Report Date
    March 16, 2025
    Manufacturer
    STRATASYS LTD.
    Product Code
    EBI
    UDI-DI
    07290018915806
    PMA / PMN Number
    K220771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN ADDITION TO THE MENTIONED BEFORE CATRIDGE NUMBER OBJ-09169, THE SAME PROBLEM OF THE CATRIDGE DATES ARE READING WRONG HAPPENED WITH OBJ-09166 (BATCH NUMBER 23123-09166, UDI 0790018915608) AND OBJ-09164 (BATCH NUMBER 22994-09164, UDI (B)(4)).

    Description of Event or Problem · 0

    THE CATRIDGE IS NOT RECOGNISED BY THE PRINTER (RFID).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689381 TRUEDENT TRUEDENT EBI STRATASYS LTD. 22861-09169 07290018915806

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown