BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILHOUETTE IC IMPLANT

    MDR report key: 846263 · Received May 4, 2007

    Report

    Report Number
    1045056-2007-00036
    Event Type
    Other
    Date Received
    May 4, 2007
    Date of Event
    November 2, 2006
    Report Date
    April 24, 2007
    Manufacturer
    BIOLOK INTERNATIONAL INC.
    Product Code
    DZS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 SILHOUETTE IC IMPLANT ENDOSSEOUS IMPLANT DZS BIOLOK INTERNATIONAL INC. IITSS410D 5718A-1

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other