BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETIIII SA FIXATION DEVICE

    MDR report key: 2817033 · Received October 27, 2012

    Report

    Report Number
    3007135442-2012-00052
    Event Type
    Injury
    Date Received
    October 27, 2012
    Report Date
    October 19, 2012
    Manufacturer
    HIOSSEN INC.
    Product Code
    DZE
    PMA / PMN Number
    K10357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DHRS FOR PRODUCTS PURCHASED BY FACILITY DID NOT SHOW ANY REWORK OR DEFECTS ASSOCIATED WITH THOSE LOTS. FAILURE TO OSSEOINTEGRATE IS A WELL-KNOWN INHERENT RISK OF DENTAL IMPLANTS. THIS IS WELL DOCUMENTED IN THE LITERATURE ACROSS IMPLANT SYSTEMS. 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

    REMOVAL OF ENDOSSEOUS IMPLANT. INITIAL COMPLAINT OF POOR INITIAL STABILITY. DOCTOR DID NOT RECORD PT ID FOR ANY OF THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETIIII SA FIXATION DEVICE DENTAL IMPLANT DZE HIOSSEN INC. ETIII UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention