BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIGOLD

    MDR report key: 6070882 · Received November 1, 2016

    Report

    Report Number
    1316092-2016-00005
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Date of Event
    September 13, 2016
    Report Date
    November 1, 2016
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Product Code
    EJT
    PMA / PMN Number
    K905326
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DOCTOR INSERTED CROWN MADE OF MINIGOLD ON (B)(6) 2016. AFTER FOUR DAYS THE PATIENT CAME BACK TO SEE THE DENTIST BECAUSE OF DISCOLORATION OF THE MINIGOLD CROWN. THE DOCTOR POLISHED THE CROWN WITH A RUBBER CUP, AND THE STAIN WENT AWAY. AFTER TWO DAYS THE CROWN BECOME DISCOLORED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722662 MINIGOLD ALLOY, GOLD-BASED NOBEL METAL EJT IVOCLAR VIVADENT, INC. 576628 V19831

    Patients

    Seq Age Sex Outcome Treatment
    1 Other