BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLO DIAMOND

    MDR report key: 17646339 · Received August 29, 2023

    Report

    Report Number
    2511556-2023-00005
    Event Type
    Malfunction
    Date Received
    August 29, 2023
    Date of Event
    July 25, 2023
    Report Date
    August 2, 2023
    Manufacturer
    PREMIER DENTAL PRODUCTS COMPANY
    Product Code
    DZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE SHANK OF THE DIAMOND BUR  BENT WHILE BEING USED WITHIN A NSK ELECTRIC HANDPIECE BEFORE IT CAME INTO CONTACT WITH THE PATIENT'S TEETH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2208900 SOLO DIAMOND DIAMOND, DENTAL BURR DZP PREMIER DENTAL PRODUCTS COMPANY M0116477

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other