BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANI DIA-BURS

    MDR report key: 10836323 · Received November 13, 2020

    Report

    Report Number
    3002692886-2020-00002
    Event Type
    Injury
    Date Received
    November 13, 2020
    Date of Event
    October 15, 2020
    Report Date
    November 13, 2020
    Manufacturer
    MANI, INC.
    Product Code
    DZP
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DURING AN ABUTMENT TEETH PREPARATION INTENDED FOR A COSMETIC TREATMENT OF TETRACYCLINE TEETH, MANI DIA-BURS (# MP-9 OF ABUTMENT TEETH PREPARATION DIA-BURS SET, NOT AVAILABLE IN THE U.S.) USED FOR THE PROCEDURE VIBRATED AND BENT, AND FRONT TEETH OF A PATIENT FRACTURED AND THE PATIENT SUFFERED LACERATION ON THE LOWER LIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302386 MANI DIA-BURS DENTAL DIAMOND BURS DZP MANI, INC. SETOF MP-1, MP-2, MP-3, MP-4, MP-5, MP-6, MP-7, MP-8, MP-9, MP-10, MP-11, MP-12F

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention