BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HG III FIXTURE SYSTEM

    MDR report key: 3062883 · Received April 12, 2013

    Report

    Report Number
    3007135442-2013-00016
    Event Type
    Injury
    Date Received
    April 12, 2013
    Report Date
    April 10, 2013
    Manufacturer
    HIOSSEN INC.
    Product Code
    DZE
    PMA / PMN Number
    K082213
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT HAS POOR BONE QUALITY. FOR INVESTIGATION, X-RAY PICTURES WERE REQUESTED BY HIOSSEN INC BUT DOCTOR REJECTED TO PROVIDE THEM. THE MOUNT SET USED FOR IMPLANTATION STAGE ONLY WAS ATTACHED TO THE FIXTURE. HIOSSEN INC IS NOT SURE WHETHER THIS PRODUCT HAS BEEN IN THE PT BONE FOR SOME PERIOD. BASED ON INSPECTION RESULTS AND THE DHR REVIEW, THE RETURNED PRODUCT HAS BEEN FOUND TO BE WITHIN SPECIFICATION. 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. THEREFORE, THE IMPLANT FAILURE IS MOST LIKELY DUE TO CAUSES OTHER THAN THE PRODUCT SUCH AS SURGICAL MISTAKE, PT BONE CONDITION, PT ORAL HYGIENE, OR PT BEHAVIOR.

    Description of Event or Problem · 1

    REMOVAL OF ENDOSSEOUS DENTAL IMPLANT AFTER TWO MONTHS OF HEALING PERIOD. THE PT HAS POOR BONE QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159039 HG III FIXTURE SYSTEM DENTAL IMPLANT DZE HIOSSEN INC. AHG3S4515R H1B10B023

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention