BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 3.75X15 SELT-TAP

    MDR report key: 149867 · Received February 21, 1998

    Report

    Report Number
    2184002-1998-00135
    Event Type
    Injury
    Date Received
    February 21, 1998
    Date of Event
    January 28, 1998
    Report Date
    February 21, 1998
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IMPLANT PLACED 12/22/1997. IT WAS REMOVED 1/21/1998 DUE TO INFECTION. ONE PERSON AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 3.75X15 SELT-TAP Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. R9005-38-15 75960421

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention