BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETCH GEL

    MDR report key: 2403094 · Received January 8, 2012

    Report

    Report Number
    2024312-2012-00007
    Event Type
    Injury
    Date Received
    January 8, 2012
    Report Date
    December 8, 2011
    Manufacturer
    PENTRON CLINICAL
    Product Code
    KLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SEATED FIBER POSTS AND CORES IN 5 TEETH USING ETCH GEL, BOND 1,CEMENT IT AND BUILD IT. ONE POST CAME OUT WHILE THE DOCTOR REMOVED THE TEMPORARY TO TRY THE FRAME. THE DOCTOR RE-CEMENTED IT WITH THE FUGI PLUS. WHEN THE PATIENT CAME BACK FOR THE PERMANENT BRIDGE TWO MORE POSTS CAME OUT SLIGHTLY. THE DOCTOR RE-SEATED THEM ALSO. THE PRODUCTS INVOLVED IN THE ALLEGED INCIDENTS WERE NOT RETURNED. AN EVALUATION OF ADHESIVE STRENGTH WAS PERFORMED ON THE RETAIN SAMPLE YIELDING RESULTS WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS RETURNED AND EVALUATED FOR ADHESIVE STRENGTH, YIELDING RESULTS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6), 2011, A DOCTOR ALLEGED THAT THREE (3) PATIENTS EXPERIENCED THE DEBONDING OR FRACTURE OF POSTS AND ONE (1) PATIENT EXPERIENCED A COMPOSITE FAILURE AFTER THE USE OF ETCH GEL AND PLACEMENT WITH BOND 1. THE DOCTOR WAS NOT DEFINITIVE AS WHICH OF THE TWO PRODUCTS WERE INVOLVED IN THE RESTORATION FAILURE OF EACH PATIENT. TWO (2) REPORTS WILL BE SUBMITTED FOR EACH PATIENT; ONE REPORT FOR EACH OF THE ALLEGED PRODUCTS; THEREFORE EIGHT TOTAL REPORTS WILL BE SUBMITTED. THIS IS THE SECOND OF EIGHT REPORTS WITH REGARD TO PATIENT #1 AND THE DEBONDING OF POST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETCH GEL AGENT, TOOTH BONDING, RESIN KLE PENTRON CLINICAL 3739004

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention FUGI PLUS| CEMENT IT| BUILD IT| BOND 1