BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTIUM

    MDR report key: 3182877 · Received June 21, 2013

    Report

    Report Number
    3005503242-2013-00005
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    April 29, 2013
    Report Date
    June 21, 2013
    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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT DEVELOPED AN INFECTION IN TOOTH LOCATION 29 AFTER BEING IMPLANTED FOR OVER TWO (2) YEARS. THE DOCTOR INDICATED INFECTION AS A CONTRIBUTING FACTOR FOR IMPLANT REMOVAL. THE PATIENT ALSO HAS A MEDICAL HISTORY OF DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283962 IMPLANTIUM ENDOSSEOUS DENTAL IMPLANT DZE DENTIUM USA FX4308MLC 07K2301

    Patients

    Seq Age Sex Outcome Treatment
    1 62 Required Intervention