BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SS WHITE CARBIDE BUR

    MDR report key: 22323746 · Received June 24, 2025

    Report

    Report Number
    2245654-2025-00011
    Event Type
    Injury
    Date Received
    June 24, 2025
    Date of Event
    May 27, 2025
    Report Date
    June 24, 2025
    Manufacturer
    SS WHITE BURS LLC
    Product Code
    EJL
    UDI-DI
    D6901406052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    N/A

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ORAL SURGEON LEARNED AFTER THE FACT THAT 5MM FRAGMENT OF THE FG-1558SL CARBIDE BUR WAS LEFT IN A PATIENT'S EXTRACTION SOCKET THAT FULLY HEALED OVER IN THE BONE WITH NO EVIDENCE OF INFECTION IN THE AREA. THE PATIENT WAS CONCERNED ABOUT GETTING AN MRI WITH THE FRAGMENTED PIECE OF THE BUR LEFT IN THE AREA. NO PATIENT INJURY NOR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1941345 SS WHITE CARBIDE BUR DENTAL BUR EJL SS WHITE BURS LLC FG-1558SL UNK D6901406052

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other