BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 3.75X10 SELF-TAPPING IMPLANT

    MDR report key: 188199 · Received September 22, 1998

    Report

    Report Number
    2184002-1998-00676
    Event Type
    Injury
    Date Received
    September 22, 1998
    Date of Event
    July 27, 1998
    Report Date
    September 22, 1998
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IMPLANT WAS PLACED 3/24/1998. IT FAILED TO INTEGRATE AND WAS REMOVED 7/27/1998. ONE PERSON AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 3.75X10 SELF-TAPPING IMPLANT Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. R9005-38-10 75980889

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention