BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREEZE CEMENT

    MDR report key: 2240294 · Received September 9, 2011

    Report

    Report Number
    2024312-2011-00232
    Event Type
    Injury
    Date Received
    September 9, 2011
    Report Date
    August 10, 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

    A DOCTOR ALLEGED THAT THREE (3) PATIENTS EACH HAD A CROWN DEBOND THAT HAD BEEN PLACED WITH THE BREEZE PRODUCT. THE RETURNED SAMPLE WAS EVALUATED AND IT WAS DETERMINED THAT THE PRODUCT WAS WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    ON (B)(6), 2011 A DOCTOR ALLEGED THAT THREE (3) PATIENTS EXPERIENCED THE DEBONDING OF CROWNS THAT HAD BEEN CEMENTED WITH BREEZE CEMENT. THIS MDR IS THE THIRD OF THREE (3) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREEZE CEMENT DENTAL CEMENT EMA PENTRON CLINICAL 3538478

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R