BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARAPOST

    MDR report key: 8731667 · Received June 25, 2019

    Report

    Report Number
    2416455-2019-00001
    Event Type
    Injury
    Date Received
    June 25, 2019
    Date of Event
    May 17, 2019
    Report Date
    June 11, 2019
    Manufacturer
    COLTENE WHALEDENT INC.
    Product Code
    ELR
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    TWO COLTENE BRAND FIBER POSTS WERE UTILIZED FOR A PATIENT, ONE ON TOOTH #3 AND ONE TOOTH #29. THE PATIENT WAS THEN SEEN TO REMOVE THE TEMPORARY CROWN AND AS PROCEEDED TO REMOVE THE TEMPORARY CROWN, THE FIBER POST IN TOOTH #3 BROKE IN HALF, LEAVING ONE END OF THE POST IN THE PATIENT'S ROOT. THE SAME PROCEDURE AND SAME PROTOCOL ON BOTH TEETH. THE FIBER POST IN TOOTH #3 FAILED AND BROKE IN HALF. THERE WAS NO MEANS FOR REMOVING THE POST AND AS A CONSEQUENCE THE TOOTH COULD NOT BE RESTORED. THE TOOTH HAD TO BE EXTRACTED AND AN IMPLANT PROCEDURE IS IN PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525311 PARAPOST POST ELR COLTENE WHALEDENT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other