BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HG III FIXTURE SYSTEM

    MDR report key: 3525601 · Received December 10, 2013

    Report

    Report Number
    3007135442-2013-00027
    Event Type
    Injury
    Date Received
    December 10, 2013
    Report Date
    November 13, 2013
    Product Code
    DZE
    PMA / PMN Number
    082213
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    FOR INVESTIGATION, X-RAY PICTURES WERE REQUESTED AND EVALUATED BY HIOSSEN INC. IT SHOWS THAT THE PATIENT HAS POOR BONE QUALITY. BASED ON VISUAL INSPECTION RESULT, X-RAY PICTURE ANALYSIS AND DHR REVIEW RESULT, 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, PATIENT BONE CONDITION, PATIENT ORAL HYGIENE, OR PATIENT BEHAVIOR.

    Description of Event or Problem · 1

    THE PATIENT HAS POOR BONE QUALITY. REMOVAL OF ENDOSSEOUS DENTAL IMPLANT DUE TO UNSUCCESSFUL OSSEOINTEGRATION. BONE GRAFTING WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643873 HG III FIXTURE SYSTEM DENTAL IMPLANT DZE AHG3S4011S H1G09B103

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention