BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT: HA, 10MM, INTEGRAL, OMNILOC, 4.0

    MDR report key: 54288 · Received December 10, 1996

    Report

    Report Number
    2023141-1996-00352
    Event Type
    Injury
    Date Received
    December 10, 1996
    Date of Event
    September 17, 1996
    Report Date
    November 15, 1996
    Manufacturer
    CALCITEK
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    DENTAL ASSISTANT

    Narratives

    Description of Event or Problem · 1

    DENTAL ASISTANT REPORTED THAT AN IMPLANT FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANT: HA, 10MM, INTEGRAL, OMNILOC, 4.0 Implant HA CYLINDER ENDOSSEOUS DENTAL IMPLANT DZE CALCITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention