BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    35005.31.052 KS1 SC KOIS

    MDR report key: 12079875 · Received June 28, 2021

    Report

    Report Number
    1032227-2021-00011
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    June 3, 2021
    Report Date
    June 28, 2021
    Manufacturer
    BRASSELER USA
    Product Code
    DZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR WAS USING THE KS1 BURS FOR CROWN PREPPING. THE BURS ARE BREAKING OFF AND THE SHANKS ARE GETTING STUCK IN THEIR HANDPIECES. THE HANDPIECES HAD TO BE REPAIRED AND HAVE THE BROKEN BUR SHANK REMOVED FROM THE HANDPIECE. THERE WERE NO PATIENTS INJURED, BUT THEY DID HAVE TO SUCTION THE BROKEN PIECES FROM THE PATIENTS' MOUTHS. THE DOCTOR DID NOT USE A RUBBER DENTAL DAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978476 35005.31.052 KS1 SC KOIS DIAMOND BURS DZP BRASSELER USA LQ4V3

    Patients

    Seq Age Sex Outcome Treatment
    1