BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPEEDCEM

    MDR report key: 1847239 · Received September 15, 2010

    Report

    Report Number
    9612352-2010-00001
    Event Type
    Other
    Date Received
    September 15, 2010
    Date of Event
    August 18, 2010
    Report Date
    September 9, 2010
    Manufacturer
    IVOCLAR VIVADENT, AG
    Product Code
    EMA
    PMA / PMN Number
    K091019
    Removal / Correction Number
    NONE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE DENTIST USED THE PRODUCT TO CEMENT 9 E.MAX CROWNS AND ACCORDING TO THE DENTIST, ALL CROWNS DEVELOPED PULPITIS AND HAD TO BE ENDODONTICALLY TREATED. THE DENTIST FAILED TO PROVIDE FURTHER INFO INCLUDING BATCH NUMBER, METHOD OF USE, ETC. TO PERMIT FURTHER INVESTIGATION. THEREFORE, WE CAN PROVIDE NO CAUSAL CONNECTION THAT THE DEVICE CAUSED THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDCEM POLYMER BASED DENTAL CEMENT EMA IVOCLAR VIVADENT, AG NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability