BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALSEAL SE

    MDR report key: 3895293 · Received June 25, 2014

    Report

    Report Number
    2016150-2014-00244
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    June 3, 2014
    Manufacturer
    SYBRONENDO
    Product Code
    KIF
    PMA / PMN Number
    K060889
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SPECIFICS WITH REGARD TO GENDER, AGE, AND WEIGHT COULD NOT BE RECALLED. THE ROOT CANAL FAILURE OCCURRED APPROXIMATELY SIX (6) MONTHS TO ONE (1) YEAR AFTER TREATMENT. THE DOCTOR STATED THAT THEY CLEANED OUT THE ROOT CANAL, FILLED IT WITH CALCIUM HYDROXIDE, AND MAY HAVE PRESCRIBED CODEINE, AMOXICILLIN, OR CLINDAMYCIN AS TREATMENT. THE DOCTOR REPORTED THAT THE PATIENT EITHER RETURNED FOR 2-3 VISITS WHICH INVOLVED CANAL CLEANING AND CALCIUM HYDROXIDE TREATMENTS, OR THE PATIENT WAS REFERRED OUT TO AN ORAL SURGEON OR PERIODONTIST FOR TOOTH REMOVAL AND/OR RESTORATIVE WORK. THE DOCTOR WAS NOT DEFINITIVE AS TO WHETHER THE PATIENT HAD FULLY RECOVERED. SYBRONENDO HAS REQUESTED THAT THE CUSTOMER REPORT ANY NEW INFORMATION WITH REGARD TO THIS PATIENT. AN UPDATE WILL BE PROVIDED IF ANY NEW INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE DOCTOR ALLEGED THAT APPROXIMATELY TWO HUNDRED FIFTY (250) PATIENTS HAD RETURNED TO THE OFFICE DUE TO PAIN AND INFECTION IN ROOT CANALS THAT HAD PREVIOUSLY BEEN TREATED WITH REALSEAL SE. THIS IS THE SIXTIETH OF TWO HUNDRED FIFTY (250) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372012 REALSEAL SE RESIN ROOT CANAL FILLING MATERIAL KIF SYBRONENDO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R