BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL BURR

    MDR report key: 21765067 · Received April 3, 2025

    Report

    Report Number
    MW5168589
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    March 31, 2025
    Report Date
    April 1, 2025
    Manufacturer
    UNKNOWN
    Product Code
    EJL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    169 - LOT L04L / EXP 2028-12-06 BUR HEAD BROKE DURING PREP. CUTTING HALF BECAME STUCK/DISLODGED INTO PATIENT'S ALVEOLAR BONE. REMOVED FRAGMENT ENTIRELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2333652 DENTAL BURR BUR, DENTAL EJL UNKNOWN 169 LO04L

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Unknown