BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 4X15 SELF-TAP

    MDR report key: 165515 · Received May 4, 1998

    Report

    Report Number
    2184002-1998-00321
    Event Type
    Injury
    Date Received
    May 4, 1998
    Date of Event
    March 27, 1998
    Report Date
    May 4, 1998
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HO
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT WAS PLACED 3/19/1998. IT WAS REMOVED 3/27/1998 DUE TO INFECTION. ONE PERSON AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 4X15 SELF-TAP Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. R9005-40-15 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention