BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HG III FIXTURE SYSTEM

    MDR report key: 3239774 · Received July 16, 2013

    Report

    Report Number
    3007135442-2013-00018
    Event Type
    Injury
    Date Received
    July 16, 2013
    Report Date
    May 28, 2013
    Manufacturer
    HIOSSEN INC.
    Product Code
    DZE
    PMA / PMN Number
    K093352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY THE DOCTOR THAT THE PATIENT HAS POOR BONE QUALITY AND IS A SMOKER. HIOSSEN INC. WAS UNABLE TO INVESTIGATE SINCE LOT NUMBER AND ACTUAL PRODUCT IS NOT AVAILABLE. 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 FAILURE OF IMPLANTATION 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

    REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. IMPLANT WAS PLACED IN SITE AREA NUMBER 13. IT IS REPORTED THAT THE PATIENT HAS POOR BONE QUALITY AND IS A SMOKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328048 HG III FIXTURE SYSTEM DENTAL IMPLANT DZE HIOSSEN INC. AHG3S4511R UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention