BEUDAMED
    FDA Adverse Event Other Summary report: N

    LASER HEX IMPLANT

    MDR report key: 846255 · Received May 4, 2007

    Report

    Report Number
    1045056-2007-00039
    Event Type
    Other
    Date Received
    May 4, 2007
    Date of Event
    February 19, 2007
    Report Date
    April 24, 2007
    Manufacturer
    BIOLOK INTERNATIONAL, INC.
    Product Code
    DZS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SEVERITY: MINIMAL. FREQUENCY: LESS THAN 2% OF ALL IMPLANTS MANUFACTURED. THE IMPLANT DOES NOT APPEAR TO HAVE BEEN DEFECTIVE IN ANY WAY.

    Description of Event or Problem · 1

    IMPLANT DID NOT INTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASER HEX IMPLANT ENDOSSEOUS IMPLANT DZS BIOLOK INTERNATIONAL, INC. LLHTSS712D 4127A-1

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other