BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ET III SA FIXTURE SYSTEM

    MDR report key: 3042121 · Received April 4, 2013

    Report

    Report Number
    3007135442-2013-00014
    Event Type
    Injury
    Date Received
    April 4, 2013
    Report Date
    March 28, 2013
    Manufacturer
    HIOSSEN INC.
    Product Code
    DZE
    PMA / PMN Number
    K101096
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    FAILED TO INTEGRATE. MOBILITY AFTER 2 MONTHS OF HEALING PERIOD. BONE GRAFT WAS DONE AFTER THE EXTRACTION. FAILURE TO OSSEOINTEGRATE IS A WELL-KNOWN INHERENT RISK OF DENTAL IMPLANTS. THIS IS WELL DOCUMENTED IN THE LITERATURE ACROSS IMPLANT SYSTEM. IN ADDITION, FAILURE TO OSSEOINTEGRATE IS INCLUDED IN THE IFU AS A KNOWN COMPLICATION WITH VARIOUS FACTORS THAT CONTRIBUTE TO THE RISK OF IMPLANT FAILURE.

    Description of Event or Problem · 1

    FAILED TO INTEGRATE. MOBILITY AFTER 2 MONTHS OF HEALING PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139233 ET III SA FIXTURE SYSTEM DENTAL IMPLANT DZE HIOSSEN INC. ET III UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention