BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPLANT: HA, INTEGRAL

    MDR report key: 67086 · Received February 7, 1997

    Report

    Report Number
    2023141-1997-00046
    Event Type
    Other
    Date Received
    February 7, 1997
    Date of Event
    September 1, 1996
    Report Date
    January 9, 1997
    Manufacturer
    CALCITEK
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS IS PART OF A CONTINUING LEGAL COMPLAINT. THE PLAINTIFF-PT ALLEGES THAT A HA COATED POST FAILED IN LOWER JAW. INFO FROM MEDWATCH REPORT #1010473.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other