BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT: HA, 10 MM, INTEGRAL, 4.0

    MDR report key: 48526 · Received November 13, 1996

    Report

    Report Number
    2023141-1996-00235
    Event Type
    Injury
    Date Received
    November 13, 1996
    Date of Event
    October 1, 1996
    Report Date
    October 15, 1996
    Manufacturer
    CALCITEK, INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTAL ASSISTANT

    Narratives

    Description of Event or Problem · 1

    DENTAL ASST REPORTED THAT AN IMPLANT FAILED DUE TO INFECTION AND BONE LOSS. PT IS SAME PT AS PRIOR MDR REPORT #M753905 AND MEDWATCH REPORT #2020141-1996-230. PT IS REPORTEDLY FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANT: HA, 10 MM, INTEGRAL, 4.0 Implant HA CYLINDER ENDOSSEOUS DENTAL IMPLANT DZE CALCITEK, INC. NA 914863

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention