BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREEZE CEMENT

    MDR report key: 2211507 · Received August 15, 2011

    Report

    Report Number
    2024312-2011-00220
    Event Type
    Injury
    Date Received
    August 15, 2011
    Report Date
    July 22, 2011
    Manufacturer
    PENTRON CLINICAL
    Product Code
    EMA
    PMA / PMN Number
    K060698
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    A DOCTOR ALLEGED THAT FOUR (4) PATIENTS EACH HAD A CROWN DEBOND THAT HAD BEEN PLACED WITH THE BREEZE PRODUCT. A RETAIN SAMPLE WAS EVALUATED AND IT WAS DETERMINED THAT THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. THE DOCTOR INDICATED HE WOULD NOT BE RETURNING THE PRODUCT; THEREFORE NO FURTHER INVESTIGATION CAN BE DONE.

    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 FIRST OF FOUR REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREEZE CEMENT DENTAL CEMENT EMA PENTRON CLINICAL 3427777

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R