BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT: HA, 13MM, INTEGRAL, 3.25

    MDR report key: 155197 · Received March 11, 1998

    Report

    Report Number
    2023141-1998-00150
    Event Type
    Injury
    Date Received
    March 11, 1998
    Date of Event
    February 10, 1998
    Report Date
    February 11, 1998
    Manufacturer
    SULZER CALCITEK
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DR. REPORTED THAT AN IMPLANT FAILED. PT IS SAME PT AS MEDWATCH REPORTS 2023141-1998-00148 AND 2023141-1998-00149.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANT: HA, 13MM, INTEGRAL, 3.25 Implant HA CYLINDER ENDOSSEOUS DENTAL IMPLANT DZE SULZER CALCITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention