BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREEZE CEMENT

    MDR report key: 2092612 · Received May 18, 2011

    Report

    Report Number
    2024312-2011-00179
    Event Type
    Injury
    Date Received
    May 18, 2011
    Report Date
    April 19, 2011
    Manufacturer
    PENTRON CLINICAL
    Product Code
    EMA
    PMA / PMN Number
    K060698
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR RECEMENTED THE CROWN WITH A DIFFERENT PRODUCT WITHOUT FURTHER INCIDENT. NO PRODUCT WAS RETURNED AND NO LOT NUMBERS WERE IDENTIFIED; THEREFORE NO FURTHER INVESTIGATION CAN TAKE PLACE AND THE CAUSE FOR THE DEBONDS REMAIN INCONCLUSIVE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A DOCTOR ALLEGED THAT FOUR PATIENTS EXPERIENCED THE DEBONDING OF CROWNS THAT HAD BEEN CEMENTED WITH BREEZE CEMENT. THIS MDR IS THE FOURTH OF FOUR REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREEZE CEMENT DENTAL CEMENT EMA PENTRON CLINICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other