BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 3.3X15 SELF-TAP+

    MDR report key: 147216 · Received February 5, 1998

    Report

    Report Number
    2184002-1998-00067
    Event Type
    Injury
    Date Received
    February 5, 1998
    Date of Event
    December 15, 1997
    Report Date
    February 4, 1998
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THREE IMPLANTS FAILED-PLACED ON 10/31/97, REMOVED ON 12/15/1997. ONE PERSON AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 3.3X15 SELF-TAP+ Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. R9010-33-15 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention