BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOHORIZONS INTERNAL DENTAL IMPLANT

    MDR report key: 827380 · Received March 8, 2007

    Report

    Report Number
    1060818-2007-00023
    Event Type
    Injury
    Date Received
    March 8, 2007
    Date of Event
    January 15, 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
    SP
    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 IMPLANTS WERE PLACED AND REMOVED THE SAME DAY BECAUSE OF PATIENT BONE QUALITY AND QUANTITY.

    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 S1106025

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other