BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SS WHITE CARBIDE BUR

    MDR report key: 21962459 · Received May 5, 2025

    Report

    Report Number
    2245654-2025-00010
    Event Type
    Malfunction
    Date Received
    May 5, 2025
    Date of Event
    March 20, 2025
    Report Date
    May 5, 2025
    Manufacturer
    SS WHITE BURS LLC
    Product Code
    EJL
    UDI-DI
    D690150012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER REPORTED BY THE CUSTOMER DOES NOT MATCH LOT NUMBERS FOR ANY SS WHITE BURS LLC PRODUCTS, AND THE REPORTED DEVICE WAS NOT RETURNED FOR INVESTIGATION. HOWEVER, AN INVESTIGATION WAS PERFORMED USING A 20-PC SAMPLE OF THE REPORTED FG-PBUR-330 PART NUMBER WAS TESTED FOR SHANK DIAMETER AND WAS WITHIN SPECIFICATION.

    Description of Event or Problem · 0

    ON (B)(6) 2025, CUSTOMER REPORTED THAT DURING A PROCEDURE, THE BUR EJECTED OUT OF HANDPIECE CAUSING SMALL GINGIVAL LACERATION. IT WAS FURTHER REPORTED THAT THE HANDPIECE WAS SET ASIDE, AND BUR WAS REMOVED. SS WHITE BURS LLC RECEIVED THE MEDWATCH #MW5168269 REPORT FROM THE FDA ON APRIL 8, 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492617 SS WHITE CARBIDE BUR DENTAL BUR EJL SS WHITE BURS LLC FG-PBUR-330 UNK D690150012

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Unknown Other