BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BUILD-IT FR

    MDR report key: 3790304 · Received May 5, 2014

    Report

    Report Number
    2024312-2014-00290
    Event Type
    Injury
    Date Received
    May 5, 2014
    Report Date
    April 17, 2014
    Manufacturer
    PENTRON CLINICAL
    Product Code
    EBF
    PMA / PMN Number
    K000211
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC INFORMATION WITH REGARD TO THE PATIENT'S AGE AND WEIGHT WAS NOT PROVIDED BY THE DOCTOR. THE PATIENT HAD EXPERIENCED THE DEBONDING OF A CORE BUILD-UP AND THE DOCTOR HAD TO REBUILD THE CORE. A NEW CROWN WILL BE MADE FOR THE PATIENT. THE DOCTOR DECLINED TO PROVIDE ANY FURTHER INFORMATION WITH REGARD TO THIS INCIDENT; THEREFORE, NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED. AN UPDATE WILL BE PROVIDED IF ANY NEW INFORMATION BECOMES AVAILABLE. THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER OR CATALOG NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT THE BUILD-IT FR CORE BUILD-UPS FOR TWO (2) PATIENTS HAD DEBONDED UPON REMOVAL OF THE TEMPORARY RESTORATION. THIS IS THE FIRST OF TWO (2) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266877 BUILD-IT FR CORE BUILD-UP MATERIAL EBF PENTRON CLINICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R CLEARFIL SE BOND