BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT: HA 8MM INTEGRAL 3.2

    MDR report key: 42639 · Received October 17, 1996

    Report

    Report Number
    2023141-1996-00149
    Event Type
    Injury
    Date Received
    October 17, 1996
    Date of Event
    August 12, 1996
    Report Date
    September 18, 1996
    Manufacturer
    CALCITEK
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DISTRIBUTOR RETURNED A FAILED IMPLANT. HE NOTED BONE RESORPTION, PT IS SAME PT AS MEDWATCH REPORTS 2023141-1996-000149 AND 2023141-1996-000150.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANT: HA 8MM INTEGRAL 3.2 Implant HA CYLINDER ENDOSSEOUS DENTAL IMPLANT DZE CALCITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention