BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREEZE SELF-ADHESIVE RESIN CEMENT

    MDR report key: 2445144 · Received February 9, 2012

    Report

    Report Number
    2024312-2012-00023
    Event Type
    Injury
    Date Received
    February 9, 2012
    Report Date
    January 10, 2012
    Manufacturer
    PENTRON CLINICAL
    Product Code
    EMA
    PMA / PMN Number
    K060698
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR WAS INFORMED THAT USING BREEZE SELF-ADHESIVE RESIN CEMENT WAS CONTRAINDICATED FOR EMPRESS CROWNS. THE BLACK STREAKS OBSERVED ON THE RESTORATIONS WERE MOST LIKELY DUE TO BACTERIAL CONTAMINATION CAUSED BY LEAKAGE INTO THE FINE CRACKS (WHICH RESULTED FROM EXPANSION) OF THE EMPRESS CROWNS, THUS THE CONTRAINDICATION. THE DOCTOR WAS ADVISED TO USE EITHER LUTE IT WITH BOND1 OR CEMENT IT DENTAL CEMENTS WHICH ARE NOT CONTRAINDICATED FOR EMPRESS CROWNS. TO DATE, THE PATIENT IS DOING FINE; HOWEVER, THE DOCTOR PLACED TEMPORARY RESTORATIONS ON THE PATIENT UNTIL HE RECEIVED THE CEMENT IT DENTAL CEMENT. DR. (B)(6) LATER REVEALED THAT THE CROWNS INVOLVED IN THE ALLEGED INCIDENT WERE E.MAX CROWNS, NOT EMPRESS CROWNS; HOWEVER, IT IS SUGGESTED THAT BECAUSE E.MAX CROWNS AND EMPRESS CROWNS ARE COMPOSED OF SIMILAR MATERIALS, BREEZE SELF-ADHESIVE RESIN CEMENT SHOULD NOT BE USED WITH E.MAX CROWNS EITHER.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT A PATIENT'S EMPRESS CROWNS HAD TO BE REMOVED DUE TO BLACK STREAKS THAT DEVELOPED IN THE CROWNS AFTER PLACEMENT WITH BREEZE SELF-ADHESIVE RESIN CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREEZE SELF-ADHESIVE RESIN CEMENT DENTAL CEMENT EMA PENTRON CLINICAL 3902221

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R