BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL BURS

    MDR report key: 21719945 · Received March 28, 2025

    Report

    Report Number
    MW5168350
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Date of Event
    March 11, 2025
    Report Date
    March 24, 2025
    Manufacturer
    SS WHITE BURS LLC
    Product Code
    EJL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DENTAL BUR BROKE AT MIDPOINT OF BUR HEAD DURING USE, WHILE OPERATING IN PATIENT'S MOUTH. FRACTURED BUR PIECE WAS WEDGED BETWEEN TEETH THAT WERE BEING TREATED, INTO CREST OF ALVEOLAR BONE. PORTION OF LOST BUR WAS RETRIEVED FROM ALVEOLUS AND REMOVED FROM PATIENT'S MOUTH. REPLACED WITH DIFFERENT BUR AND CONTINUED WITH TREATMENT. PARENTS NOTIFIED OF EVENT. BUR # FG-169 / REF: 10801 / LOT: L04L / EXP: 2028-12-06 / BRAND SS WHITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010442 DENTAL BURS BUR, DENTAL EJL SS WHITE BURS LLC L04L

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Female