BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETIII SA FIXATION DEVICE

    MDR report key: 2817118 · Received October 27, 2012

    Report

    Report Number
    3007135442-2012-00013
    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
    GA, 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 AT FINAL RESTORATION, IMPLANT CAME OFF WITH ABUTMENT. DOCTOR RECALLS PATIENT HAD POOR BONE QUALITY AND NEEDED A LARGER IMPLANT. DOCTOR DID NOT RECORD PATIENT ID FOR ANY OF THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETIII SA FIXATION DEVICE DENTAL IMPLANT DZE HIOSSEN, INC. ETIII H1G10A040

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention