BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISS 3.75X13 SELF-TAP+

    MDR report key: 49966 · Received November 20, 1996

    Report

    Report Number
    2184002-1996-00270
    Event Type
    Injury
    Date Received
    November 20, 1996
    Date of Event
    October 23, 1996
    Report Date
    November 19, 1996
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT WAS PLACED 3/19/96 AND REMOVED 10/23/96. ONE PERSON AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISS 3.75X13 SELF-TAP+ Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. ISS963 75950169

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention