BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBREKOR POST

    MDR report key: 3836884 · Received May 28, 2014

    Report

    Report Number
    2024312-2014-00424
    Event Type
    Injury
    Date Received
    May 28, 2014
    Report Date
    May 1, 2014
    Manufacturer
    PENTRON CLINICAL
    Product Code
    ELR
    PMA / PMN Number
    K983266
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WITH REGARD TO GENDER, AGE, AND WEIGHT WAS NOT PROVIDED. A NEW POST AND CORE WAS CREATED FOR THE PATIENT. THE DOCTOR RETROFITTED THE NEW POST AND CORE TO THE ORIGINAL CROWN AND CEMENTED IT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT 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'S OFFICE ALLEGED THAT SEVEN (7) PATIENTS HAD EXPERIENCED THE DEBONDING OF A FIBREKOR FIBER POST WITH THE CORE AND CROWN STILL ATTACHED. THIS IS THE SIXTH OF SEVEN (7) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313797 FIBREKOR POST ROOT CANAL POST ELR PENTRON CLINICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R MULTILINK CEMENT| MULTILINK BONDING AGENT