BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIXTURE REMOVER SCREW M2.0

    MDR report key: 6130271 · Received November 28, 2016

    Report

    Report Number
    0001038806-2016-00315
    Event Type
    Injury
    Date Received
    November 28, 2016
    Report Date
    October 28, 2016
    Manufacturer
    NEOBIOTECH CO. LTD.
    Product Code
    DZA
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS DISCARDED BY DENTIST.

    Description of Event or Problem · 1

    THE DENTIST REPORTED THAT THE FIXTURE REMOVAL SCREW FRACTURED WITHIN THE IMPLANT. THE SCREW FRAGMENT WAS REMOVED AND THE IMPLANT REMAINS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780081 FIXTURE REMOVER SCREW M2.0 FIXTURE REMOVER SCREW DZA NEOBIOTECH CO. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention