BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERLINE

    MDR report key: 4141324 · Received October 3, 2014

    Report

    Report Number
    3005503242-2014-00014
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    August 26, 2014
    Report Date
    October 3, 2014
    Manufacturer
    DENTIUM USA
    Product Code
    DZE
    PMA / PMN Number
    K041368
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT DEVELOPED AN INFECTION IN TOOTH LOCATION 21 AFTER THE FIXTURE WAS IMPLANTED FOR OVER ONE AND A HALF (1 1/2) YEARS. THE DOCTOR INDICATED INFECTION WAS THE ONLY CONTRIBUTING FACTOR FOR IMPLANT REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619877 SUPERLINE ENDOSSEOUS DENTAL IMPLANT DZE DENTIUM USA FX4512SWC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention