BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREEZE SELF-ADHESIVE RESIN CEMENT

    MDR report key: 3132025 · Received May 29, 2013

    Report

    Report Number
    2024312-2013-00206
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    April 29, 2013
    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

    ALTHOUGH THE DOCTOR IDENTIFIED FOUR (4) DIFFERENT LOTS ASSOCIATED WITH THE CEMENT NOT SETTING UP, HE COULD NOT VERIFY WHICH LOT WAS USED ON THE PATIENT; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED IN THIS REPORT. THE LOT NUMBERS INVOLVED IN THE ALLEGED INCIDENTS INCLUDE 4093633 (LISTED ON THIS COMPLAINT), 4093634 (LISTED ON COMPLAINT #(B)(4)), 4404088 (LISTED ON COMPLAINT #(B)(4)), AND 4435124 (LISTED ON COMPLAINT #(B)(4)); HOWEVER, THE DOCTOR COULD NOT RECALL PATIENT OR INCIDENT DETAILS AND WAS NOT DEFINITIVE AS TO THE NUMBER OF PATIENTS AFFECTED WITH REGARD TO EACH LOT. PATIENT SPECIFICS WITH REGARD TO AGE AND WEIGHT WERE NOT PROVIDED BY THE DOCTOR. THE DOCTOR CEMENTED A NEW CROWN FOR THE PATIENT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT WAS NOT RETURNED. EVALUATIONS FOR LOT NUMBER 4093633 (LISTED ON COMPLAINT #(B)(4)) WERE PERFORMED UNDER LOT NUMBER 4093634. LOT NUMBER 4093634 CAME FROM THE SAME BATCH AS THE LOT NUMBER 4093633 (LISTED ON COMPLAINT #(B)(4)). A VISUAL AND PHYSICAL EVALUATION WAS PERFORMED ON RETAINED SAMPLES FROM LOT NUMBER 4093634, YIELDING RESULTS WITHIN SPECIFICATIONS. A VISUAL AND PHYSICAL EVALUATION WAS PERFORMED ON RETAINED SAMPLES FROM LOT NUMBERS 4093634 (LISTED ON COMPLAINT #(B)(4)), 4404088 (LISTED ON COMPLAINT #(B)(4)), AND 4435124 (LISTED ON COMPLAINT #(B)(4)), YIELDING RESULTS WITHIN SPECIFICATIONS. IN ADDITION, A DHR REVIEW INDICATED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS WITH REGARD TO ANY OF THESE LOTS.

    Description of Event or Problem · 1

    A DOCTOR'S OFFICE ALLEGED THAT A PATIENT HAD EXPERIENCED THE CRACKING AND DEBONDING OF A CROWN AFTER PLACEMENT WITH BREEZE SELF ETCH CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234536 BREEZE SELF-ADHESIVE RESIN CEMENT DENTAL CEMENT EMA PENTRON CLINICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R