BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HG III FIXTURE SYSTEM

    MDR report key: 3042145 · Received April 4, 2013

    Report

    Report Number
    3007135442-2013-00012
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    February 22, 2012
    Report Date
    March 28, 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

    REVIEW OF DHR FOR PRODUCTS 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.

    Description of Event or Problem · 1

    IMPLANT WAS REMOVED AND GRAFT MATERIAL WAS PLACED. IMPLANT WAS PLACED TOO BUCCAL AND RESULTED IN BONE LOSS AND IMPLANT FAILED TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139277 HG III FIXTURE SYSTEM DENTAL IMPLANT DZE HIOSSEN INC. HG III HIGI0B029

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention