BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SS WHITE CARBIDE BUR

    MDR report key: 23610016 · Received November 20, 2025

    Report

    Report Number
    2245654-2025-00014
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Report Date
    November 20, 2025
    Manufacturer
    SS WHITE BURS LLC
    Product Code
    EJL
    UDI-DI
    D690133302
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS CONDUCTED ON PRODUCT FROM THE SAME LOT AS THE REPORTED DEVICE WAS RETRIEVED AND EVALUATED. DIMENSIONAL INSPECTION CONFIRMED THAT THE SHANK DIAMETERS WERE WITHIN SPECIFICATIONS AND MET ALL APPLICABLE ACCEPTANCE CRITERIA. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 0

    SS WHITE WAS MADE AWARE ON OCTOBER 23, 2025, THAT DURING A DENTAL PROCEDURE THAT WAS PERFORMED ON AN UNKNOWN DATE, THE DENTIST STATED THAT THE CARBIDE BUR THAT WAS USED (FG330) WAS "LOOSE AND SLIPPING". WHILE THE DENTIST WAS USING THIS BUR ON THE PATIENT, THE BUR SLIPPED DOWN THE PATIENT'S THROAT AND THE PATIENT HAD TO HAVE X-RAYS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314365 SS WHITE CARBIDE BUR DENTAL BUR EJL SS WHITE BURS LLC FG-PBUR-330 L05I D690133302

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other