BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT: HA, 8MM INTEGRAL OMN LOC, 3.25

    MDR report key: 40543 · Received October 3, 1996

    Report

    Report Number
    2023141-1996-00095
    Event Type
    Injury
    Date Received
    October 3, 1996
    Date of Event
    August 22, 1996
    Report Date
    September 5, 1996
    Manufacturer
    CALCITEK
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    A PT HAD GOOD OCCULSION, IMPLANT INTEGRATED, EVERYTHING FINE UNTIL AUGUST, IMPLANT BECAME MOBILE, NO INFECTION, TOOTH SITE #30. PT SHOWED NO SYMPTOMS. DR. FINDS NO REASON FOR FAILURE, THERE WAS PLENTY OF BONE. PT SAME PT AS PRIOR MDR REPORT #M589905.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANT: HA, 8MM INTEGRAL OMN LOC, 3.25 Implant HA CYLINDER ENDOSSOUES DENTA IMPLANT DZE CALCITEK NA 9644118

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention