BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESILON

    MDR report key: 3088642 · Received April 28, 2013

    Report

    Report Number
    MW5029996
    Event Type
    Injury
    Date Received
    April 28, 2013
    Date of Event
    February 1, 2009
    Report Date
    April 28, 2013
    Manufacturer
    SYBRON ENDO
    Product Code
    EKR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    I WAS USING RESILON ROOT CANAL FILLING MATERIAL W/EPIPHANY SEALER FROM (B)(6) 2004 - (B)(6)2009. THIS PRODUCT WAS PRODUCED BY PENTRON CORP WITH THE RIGHTS FOR IT'S SALE REQUIRED BY SYBRON DENTAL SPECIALTIES. IT WASN'T UNTIL MANY YRS AFTER IT'S USAGE THAT MULTIPLE FAILURES HAVE OCCURRED. PTS ARE RETURNING WITH NUMEROUS INFECTIONS COMPROMISING THOUSANDS OF DOLLARS IN DENTAL TREATMENT. UPON REENTERING THESE TEETH, I FIND THAT THE MATERIAL HAS DECOMPOSED LEAVING A BACTERIA FILLED MESS. THE PRODUCT NEVER BONDS TO THE TEETH OR STRENGTHENS ROOTS, AS ADVERTISED. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183180 RESILON ROOT CANAL FILLING MATERIAL EKR SYBRON ENDO
    183181 EPIPHANY SEALER SEALER KIF SYBRON ENDO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other