BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLO DIAMOND

    MDR report key: 12913555 · Received December 1, 2021

    Report

    Report Number
    2511556-2021-00005
    Event Type
    Injury
    Date Received
    December 1, 2021
    Date of Event
    November 18, 2021
    Report Date
    December 1, 2021
    Manufacturer
    PREMIER DENTAL PRODUCTS COMPANY
    Product Code
    DZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE PREPPING A #2 BUILD-UP, DENTIST SWITCHED TO SWITCHED TO THE SOLO BUR FOR OCCLUSAL REDUCTION. BUR SPUN-OUT AND BENT AT THE SHAFT STRIKING THE TOOTH AND BREAKING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1811752 SOLO DIAMOND DENTAL DIAMOND DZP PREMIER DENTAL PRODUCTS COMPANY SOLO 2137C

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| O