BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BUILD IT FR

    MDR report key: 2414324 · Received January 12, 2012

    Report

    Report Number
    2024312-2012-00019
    Event Type
    Injury
    Date Received
    January 12, 2012
    Date of Event
    December 14, 2011
    Report Date
    December 14, 2011
    Manufacturer
    PENTRON CLINICAL
    Product Code
    EBF
    PMA / PMN Number
    K000211
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REMOVED THE CORE FROM THE PATIENT'S MOUTH AND REPLACED IT SUCCESSFULLY WITH A DIFFERENT PRODUCT. NO PRODUCT WAS RETURNED BY THE CUSTOMER. A RETAIN SAMPLE WAS EVALUATED FOR GEL TIME, SET TIME AND BARCOL HARDNESS. THE PRODUCT MET SPECIFICATIONS. DURING EVALUATION NO SWELLING OF THE PRODUCT WAS NOTED.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT WHILE USING THE BUILD IT FR CARTRIDGE THE PRODUCT EXPANDED WHEN IT WAS LIGHT CURED AND THEN SWELLED UP. IT HAD TO BE CUT BACK. DURING THE SAME PROCEDURE THE DOCTOR NOTICED THAT THE CORE MOVED DURING REMOVAL OF THE TEMPORARY CROWN. THE CORE COMPLETELY SEPARATED FROM THE BOND AND TOOTH STRUCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUILD IT FR CORE BUILD-UP MATERIAL EBF PENTRON CLINICAL 3666457

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention