BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIKIN

    MDR report key: 18600800 · Received January 29, 2024

    Report

    Report Number
    2416455-2024-00001
    Event Type
    Malfunction
    Date Received
    January 29, 2024
    Date of Event
    December 27, 2023
    Report Date
    April 5, 2024
    Manufacturer
    COLTENE WHALEDENT INC.
    Product Code
    DZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON 12/27 THE CUSTOMER STATED THAT THE L511 PIN DRIVER BROKE IN THE PATIENT'S MOUTH. THE CUSTOMER STATED THAT THE PATIENT WAS NOT HURT. THE CUSTOMER THEN PROVIDED AN ASSESSMENT FORM WHERE THEY STATED THAT THE DRIVER SEPARATED IN THE PATIENT'S TOOTH WHILE MAKING THE PIN HOLE. PER THE CUSTOMER, THE DRILL WAS THEN LEFT IN THE PATIENT'S TOOTH TO ACT AS THE "PIN" AGAINST THE DRILLS INDICATIONS. THEREFORE, OUT OF AN ABUNDANCE OF CAUTION AND PER 21 CFR 803, THIS EVENT WILL BE REPORTED TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2545188 MINIKIN DENTAL DRILL DZA COLTENE WHALEDENT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown