BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SS WHITE CARBIDE BUR

    MDR report key: 22568901 · Received July 22, 2025

    Report

    Report Number
    2245654-2025-00012
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Report Date
    July 22, 2025
    Manufacturer
    SS WHITE BURS LLC
    Product Code
    EJL
    UDI-DI
    D690300242
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE WAS NOT RETURNED FOR INVESTIGATION. HOWEVER, AN INVESTIGATION WAS PERFORMED. A FORCE TO FAILURE TEST WAS CONDUCTED USING A 10-PIECE SAMPLE FROM A DIFFERENT LOT NUMBER. RESULTS SHOWED TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2025 THAT DURING THE DENTAL PROCEDURE THE TIP OF BUR BROKE OFF IN A PATIENT'S MOUTH. NO PATIENT INJURY WAS REPORTED AND NO EVENT DATE WAS REPORTED. SS WHITE BURS RECEIVED MEDWATCH REPORT MW5171690 ON JULY 2, 2025, FROM THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1659730 SS WHITE CARBIDE BUR DENTAL BUR EJL SS WHITE BURS LLC HP-PBUR-SC702LA LO4L D690300242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other