BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYBRONENDO

    MDR report key: 7543397 · Received May 24, 2018

    Report

    Report Number
    2016150-2018-00019
    Event Type
    Malfunction
    Date Received
    May 24, 2018
    Report Date
    May 24, 2018
    Manufacturer
    SYBRONENDO
    Product Code
    EKZ
    PMA / PMN Number
    K031664
    Removal / Correction Number
    Z-0413-2018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC INFORMATION WITH REGARD TO THE EXACT NUMBER OF PATIENTS AFFECTED, GENDERS, AGES, AND WEIGHTS WAS NOT PROVIDED. THE DATE OF EVENT WAS NOT PROVIDED. DEVICE MANUFACTURE DATE IS PENDING. THE DOCTOR REPORTED THAT WHEN ROOT CANALS FAILED EXTRACTIONS HAD TO BE DONE AND IMPLANTS INSERTED. THE PRODUCT HAS BEEN IDENTIFIED AS AN AFFECTED PRODUCT IN AN ONGOING CLASS II RECALL; THEREFORE, NO FURTHER EVALUATION IS NECESSARY.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT THERE WERE CASES WERE POSTOPERATIVE SENSITIVITY AND ROOT CANAL FAILURE HAD OCCURED WHEN USING THE ELEMENTS OBTURATION UNIT WITH BUCHANAN TIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383675 SYBRONENDO ELEMENTS OBTURATION UNIT, EKZ SYBRONENDO

    Patients

    Seq Age Sex Outcome Treatment
    1