BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIER ROOT CANAL EXPLORER

    MDR report key: 23403420 · Received October 28, 2025

    Report

    Report Number
    2511556-2025-00004
    Event Type
    Injury
    Date Received
    October 28, 2025
    Date of Event
    September 22, 2025
    Report Date
    October 27, 2025
    Manufacturer
    PREMIER DENTAL PRODUCTS COMPANY
    Product Code
    EKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE INSTRUMENT BENT BACKWARDS WHILE DOCTOR IS SEARCHING FOR A CANAL OPENING AND THEN SLIDING OUT OF THE PATIENT'S TEETH AND MOUTH AND INIJURING PATIEN'S FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1551947 PREMIER ROOT CANAL EXPLORER EXPLORER, OPERATIVE EKB PREMIER DENTAL PRODUCTS COMPANY ZN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention