BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HG III FIXTURE SYSTEM

    MDR report key: 3239741 · Received July 16, 2013

    Report

    Report Number
    3007135442-2013-00022
    Event Type
    Injury
    Date Received
    July 16, 2013
    Report Date
    July 10, 2013
    Manufacturer
    HIOSSEN INC.
    Product Code
    DZE
    PMA / PMN Number
    K093352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY THE DOCTOR THAT THE PT HAS POOR BONE QUALITY. SINCE 2 YRS HEALING PERIOD IS NOT USUAL, HIOSSEN INC HAS CONTACTED THE DOCTOR FOR X-RAY BUT HE REFUSED TO PROVIDE IT. THE INVESTIGATION WAS LIMITED TO THE RETURNED PRODUCT AND DEVICE HISTORY RECORD. BASED ON INSPECTION RESULTS AND THE DHR REVIEW, THE RETURN 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 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. 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

    IMPLANT WAS PLACED IN SITE AREA #11 ON (B)(6) 2011 AND IT JUST FELL OUT AFTER 2 YRS WHEN HE CAME FOR CLEANING. DR REPLACED IT USING A ET SAME SIZE FIXTURE. IT IS REPORTED THAT THE PT HAS POOR BONE QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327972 HG III FIXTURE SYSTEM DENTAL IMPLANT DZE HIOSSEN INC. AHG33S4010R H1G10B068

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention