BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREEZE CEMENT

    MDR report key: 4393584 · Received January 7, 2015

    Report

    Report Number
    2024312-2015-00001
    Event Type
    Injury
    Date Received
    January 7, 2015
    Date of Event
    November 12, 2014
    Report Date
    December 10, 2014
    Manufacturer
    PENTRON CLINICAL
    Product Code
    EMA
    PMA / PMN Number
    K060698
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT INFORMATION SUCH AS AGE AND WEIGHT WAS NOT PROVIDED. THE PATIENT REPORTED IN (B)(6) 2014 THAT TWO (2) OF THE ONLAYS WHICH WERE PLACED IN (B)(6) OF 2014 HAD FELT LOOSE. UPON REMOVAL, THE DENTIST REPORTED THAT THE BREEZE CEMENT HAD NOT SET AND THE PATIENT HAD EXPERIENCED MICROLEAKAGE AND TOOTH DECAY. THE DOCTOR PLACED A ZOE FILLING ON ONE (1) TOOTH, AND REFERRED THE PATIENT TO AN ENDODONTIST FOR THE SECOND TOOTH. A ROOT CANAL WAS PERFORMED BY THE ENDODONTIST FOR THE SECOND TOOTH. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED; THEREFORE, A CHEMICAL EVALUATION WAS PERFORMED ON A RETAINED SAMPLE FROM THE SAME LOT, YIELDING RESULTS WITHIN SPECIFICATIONS. A DHR REVIEW INDICATED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO THIS LOT.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT ONE (1) PATIENT HAD EXPERIENCED MICROLEAKAGE AND TWO (2) PATIENTS HAD EXPERIENCED THE DEBONDING OF AN ONLAY AFTER PLACEMENT WITH THE BREEZE CEMENT. THIS IS THE FIRST OF THREE (3) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13742 BREEZE CEMENT DENTAL CEMENT EMA PENTRON CLINICAL 5209830

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R