BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT: HA, SPLINE, 10MM, 3.25

    MDR report key: 196214 · Received November 12, 1998

    Report

    Report Number
    2023141-1998-00861
    Event Type
    Injury
    Date Received
    November 12, 1998
    Date of Event
    October 13, 1998
    Report Date
    October 14, 1998
    Manufacturer
    SULZER CALCITEK
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DENTAL ASSISTANT REPORTED THAT AN IMPLANT FAILED TO INTEGRATE. PT IS REPORTEDLY FINE. PT IS SAME PT AS MEDWATCH REPORT #2923141-1998-862.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANT: HA, SPLINE, 10MM, 3.25 Implant HA CYLINDER ENDOSSEOUS DENTAL IMPLANTS DZE SULZER CALCITEK NA 972166

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention