BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOHORIZONS INTERNAL DENTAL IMPLANT

    MDR report key: 827391 · Received March 8, 2007

    Report

    Report Number
    1060818-2007-00024
    Event Type
    Injury
    Date Received
    March 8, 2007
    Date of Event
    February 16, 2007
    Report Date
    March 8, 2007
    Manufacturer
    BIOHORIZONS IMPLANT SYSTEMS, INC.
    Product Code
    DZE
    PMA / PMN Number
    k042429
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANT WAS NOT FRACTURED. THE IMPLANT WAS EXAMINED UNDER 20X MAGNIFICATION AND NO THREAD DEFECTS WERE NOTED. THE IMPLANT UNIT RETURNED WAS WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    REMOVAL OF DENTAL IMPLANT. THE CLINICIAN REPORTED THE IMPLANT WAS PLACED AND REMOVED THE SAME DAY BECAUSE OF PERI-IMPLANTITIS AND PATIENT BONE QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOHORIZONS INTERNAL DENTAL IMPLANT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE BIOHORIZONS IMPLANT SYSTEMS, INC. NA S0406030

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other