BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ET III SA FIXTURE SYSTEM

    MDR report key: 3042112 · Received April 4, 2013

    Report

    Report Number
    3007135442-2013-00003
    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
    MD, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DHR FOR PRODUCT PURCHASED BY FACILITY DID NOT SHOW ANY DEFECTS ASSOCIATED WITH THE LOT. 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. PATIENT HAD POOR BONE QUALITY AND BAD ORAL HYGIENE.

    Description of Event or Problem · 1

    DID NOT INTEGRATE 1ST SURGERY ATTEMPT. THE IMPLANT WAS REMOVED AND REPLACED WITH OTHER PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138893 ET III SA FIXTURE SYSTEM DENTAL IMPLANT DZE HIOSSEN INC. ET III H1E11I027

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention