BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOHORIZONS EXTERNAL DENTAL IMPLANT

    MDR report key: 758061 · Received September 1, 2006

    Report

    Report Number
    1060818-2006-00039
    Event Type
    Injury
    Date Received
    September 1, 2006
    Date of Event
    December 2, 2005
    Manufacturer
    BIOHORIZONS IMPLANT SYSTEMS, INC.
    Product Code
    DZE
    PMA / PMN Number
    K030463
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANT WAS RECEIVED WITHOUT ANY ATTACHMENTS AND WAS NOT FRACTURED. THE IMPLANT WAS EXAMINED UNDER 10X MAGNIFICATION AND NO THREAD DEFECTS WERE FOUND. THE IMPLANT WAS THEN COMPARED TO A L02050 REV/10/03 RADIOGRAPHIC TEMPLATE AND WAS DETERMINED TO BE A PH4MM X 9MM IMPLANT.

    Description of Event or Problem · 1

    REMOVAL OF DENTAL IMPLANT. THE CLINICIAN REPORTED IMPLANT WAS PLACED IN THIN CORTICAL BONE IN 2005. THE COVER SCREW WAS LOOSE WHEN CLINICIAN MADE THE SECOND STAGE SURGERY. THE CLINICIAN OPENED THE FLAP AND DISCOVERED THE IMPLANT STABILITY WAS NOT GOOD, SO HE REMOVED THE IMPLANT SIX MONTHS LATER, AND UNDERWENT THE GBR SURGERY. THE CLINICIAN IDENTIFIED THE REASON OF REMOVAL AS FAILURE-TO-OSSEOINTEGRATE RESULTING FROM PATIENT POOR ORAL HYGEINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOHORIZONS EXTERNAL DENTAL IMPLANT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE BIOHORIZONS IMPLANT SYSTEMS, INC. NA S0604005

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other