BEUDAMED
    FDA Adverse Event Injury Summary report: N

    330 PEAR CARBIDE DENTAL BUR

    MDR report key: 23444540 · Received November 3, 2025

    Report

    Report Number
    MW5178427
    Event Type
    Injury
    Date Received
    November 3, 2025
    Date of Event
    October 14, 2025
    Report Date
    October 28, 2025
    Manufacturer
    SS WHITE BURS LLC
    Product Code
    EJL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2025 DENTIST REPORTS: BROKEN DENTAL BUR DENTIST REPORTS WHILE DRILLING OUT SOME TOOTH DECAY. DENTIST REPORTS: THE BUR THAT BROKE WAS A "330 PEAR CARBIDE" MANUFACTURED BY SS WHITE. THIS IS ACTUALLY THE FOURTH INCIDENT THIS YEAR OF THIS PARTICULAR MODEL OF BUR BY THIS PARTICULAR COMPANY BREAKING IN THE MIDDLE OF DRILLING OUT ROUTINE TOOTH DECAY. THE FIRST FEW TIMES I THOUGHT IT WAS JUST A MANUFACTURING DEFECT OR THE ANGULATION OF THE CAVITY WAS TOUGH ON THE BUR. CHIEF DENTIST REPORTS: CHIEF DENTAL SERVICES REPORTS: ALL DENTAL PROVIDERS SENT EMAIL COMMUNICATION TO ALERT THEM TO QUALITY ISSUE WITH BUR. NO PROVIDERS REPORTED RECENT INCIDENT WITH THIS DENTAL BUR OR OTHER DENTAL BURS, LAST REPORTED INCIDENT 4 YEARS AGO. ONLY SINGLE USE, PRE-STERILIZED BURS ARE UTILIZED IN THE DENTAL SERVICE AND ARE SINGLE USE ITEMS AND THE DENTIST MAY NEED TO USE MULTIPLE BURS DURING ONE PROCEDURE. DENTAL PROVIDERS MADE AWARE OF POTENTIAL SAFETY ISSUE BY EMAIL AND IN MORNING HUDDLES. A NEW BRAND SELECTED OF THE 330 DENTAL BUR WAS SELECTED FOR THIS FOR FUTURE USE. PT CODE: 4582. DEVICE CODE: 1069. REF REPORTS: MW5178425, MW5178426, MW5178428.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1067094 330 PEAR CARBIDE DENTAL BUR BUR, DENTAL EJL SS WHITE BURS LLC SHAK: FG SHAPE:PEAR

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Other