BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILHOUETTE IC IMPLANT

    MDR report key: 846260 · Received May 4, 2007

    Report

    Report Number
    1045056-2007-00038
    Event Type
    Other
    Date Received
    May 4, 2007
    Date of Event
    August 12, 2005
    Report Date
    April 24, 2007
    Manufacturer
    BIOLET INTERNATIONAL INC.
    Product Code
    DZS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    EXPLANT DID NOT INTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILHOUETTE IC IMPLANT ENDOSSEOUS IMPLANT DZS BIOLET INTERNATIONAL INC. IITSS412D 4640A

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other