BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN

    MDR report key: 23144057 · Received September 25, 2025

    Report

    Report Number
    2411236-2025-00002
    Event Type
    Injury
    Date Received
    September 25, 2025
    Date of Event
    August 13, 2025
    Report Date
    September 25, 2025
    Manufacturer
    PRIMA DENTAL GROUP
    Product Code
    EJL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A PROCEDURE THE BUR WAS BEING USED IN AN X CUBE MOTORS WITH RAM STRAIGHT HANDPIECE WHEN IT BROKE AND REMAINED IN A PATIENT'S MOUTH. THE PATIENT MAY NEED TO GO FOR AN ADDITIONAL PROCEDURE TO HAVE IT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2431166 HENRY SCHEIN CARBIDE BUR HP 703 EJL PRIMA DENTAL GROUP 1615592

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O