BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT: HA, 13MM, INTEGRAL OMNLIOC, 3.25

    MDR report key: 95979 · Received June 5, 1997

    Report

    Report Number
    2023141-1997-00431
    Event Type
    Injury
    Date Received
    June 5, 1997
    Date of Event
    February 16, 1997
    Report Date
    May 7, 1997
    Manufacturer
    SULZER CALCITEK INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    AN IMPLANT FAILED IN FUNCTION. PT IS SAME PT AS MEDWATCH REPORTS #2023141-1997-00432 AND 2023141-1997-00433.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention