BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SS WHITE CARBIDE BUR

    MDR report key: 24074949 · Received January 14, 2026

    Report

    Report Number
    2245654-2026-00016
    Event Type
    Injury
    Date Received
    January 14, 2026
    Date of Event
    December 10, 2025
    Report Date
    January 14, 2026
    Manufacturer
    SS WHITE BURS LLC
    Product Code
    EJL
    UDI-DI
    D6901405852
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED BUR WAS NOT RETURNED FOR EVALUATION. HOWEVER, AN INVESTIGATION WAS PERFORMED ON THE SAME PART NUMBER FROM A DIFFERENT LOT. NECK STRENGTH TESTING ON THE 20-PIECE SAMPLE WAS PERFORMED AND ALL 20 SAMPLES PASSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HEAD OF A SURGICAL BUR BROKE OFF INTO THE JAW OF A PATIENT DURING A WISDOM TOOTH EXTRACTION PROCEDURE ON (B)(6) 2025. A POST-OPERATIVE IMAGE WAS TAKEN TO VERIFY THE LOCATION OF THE BROKEN BUR WHICH REVEALED A FRAGMENT OF THE BUR WAS LEFT BEHIND IN AREA #3. IT WAS FURTHER REPORTED THAT RETRIEVAL OF THE FRAGMENT OF THE BUR CAN CAUSE NERVE DAMAGE AS IT IS CLOSE TO THE IAN. A 3DCT WAS TAKEN AT A POST-OP VISIT SHOWING THE FRAGMENTED BUR APPEARING TO BE PERFORATING TISSUE AND WORKING OUTWARD NEAR THE EXTRACTION SITE. THE PATIENT WAS ADVISED TO BE AWARE OF TISSUE SENSITIVITY IN RIGHT LINGUAL AREA. PATIENT WAS FURTHER ADVISED THAT IF SHE FEELS A SHARP AND IRRITATING OBJECT, TO RETURN TO RETRIEVE THE BUR. OTHERWISE, PATIENT WILL RETURN FOR A SIX-MONTH FOLLOW-UP REPEAT 3DCT IMAGING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127814 SS WHITE CARBIDE BUR DENTAL BUR EJL SS WHITE BURS LLC FG-558SL L05J D6901405852

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female Other