BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOHORIZONS EXTERNAL DENTAL IMPLANT

    MDR report key: 826236 · Received March 6, 2007

    Report

    Report Number
    1060818-2007-00020
    Event Type
    Injury
    Date Received
    March 6, 2007
    Date of Event
    January 30, 2007
    Report Date
    March 6, 2007
    Manufacturer
    BIOHORIZONS IMPLANT SYSTEMS, INC.
    Product Code
    DZE
    PMA / PMN Number
    k030463
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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 IDENTIFIED THE IMPLANT WAS REMOVED THE SAME DAY BECAUSE OF LACK OF PRIMARY STABILITY.

    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 S0505004

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other