BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SS WHITE

    MDR report key: 24926438 · Received April 20, 2026

    Report

    Report Number
    MW5186968
    Event Type
    Injury
    Date Received
    April 20, 2026
    Date of Event
    January 27, 2026
    Report Date
    April 15, 2026
    Manufacturer
    TRIROCK DENTAL LLC.
    Product Code
    EJL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SURGICAL BUR USED TO EXTRACT IMPACTED WISDOM TOOTH OF THE RIGHT MANDIBLE. BUR FRAGMENT NOTED POST OPERATIVELY ON CT SCAN TAKEN DUE TO RIGHT TONGUE NUMBNESS NOT RESOLVING. RADIO OPAQUE OBJECT NOTED IN FLOOR OF THE MOUTH. PATIENT UNABLE TO GET AN MRI TO DETERMINE EXTENT OF NERVE INVOLVEMENT OF THE TONGUE. EMBEDDED IN THE TISSUE FLOOR OF MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224363 SS WHITE BUR, DENTAL EJL TRIROCK DENTAL LLC. FG-1702SL L04A

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Disability| R