BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOHORIZONS EXTERNAL DENTAL IMPLANT

    MDR report key: 757304 · Received September 1, 2006

    Report

    Report Number
    1060818-2006-00032
    Event Type
    Injury
    Date Received
    September 1, 2006
    Report Date
    September 1, 2006
    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 WITH A COVER SCREW ATTACHED AND AN ABUTMENT SCREW AND NON PREPPED ABUTMENT. THE IMPLANT WAS NOT FRACTURED AND WAS EXAMINED UNDER 10X MAGNIFICATION. THERE WAS NOT ANY THREAD DEFECTS NOTED. THE IMPLANT WAS THEN COMPARED TO A L0250 REV 10/03 RADIOGRAPHIC TEMPLATE AND WAS DETERMINED TO BE A D5MM X 9MM IMPLANT.

    Description of Event or Problem · 1

    THE CLINICIAN SAID IMPLANT WAS PLACED IN 2005 AND THE CORNER SCREW WAS LOOSE DECEMBER 02, 2005, WHEN THE CLINICIAN MADE THE SECOND STAGE SURGERY. THE CLINICIAN OPENED THE FLAP AND DISCOVERED THE IMPLANT STABILITY WAS NOT GOOD, SO HE REMOVED IMPLANT AND UNDERWENT THE GBR SURGERY. THE CLINICIAN IDENTIFIED THE REASON OF REMOVAL AS FAILURE-TO-OSSEOINTEGRATE RESULTING FROM INFECTION AND PATIENT POOR ORAL HYGIENE.

    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 S0204011

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other