BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 4X13 SELF-TAP

    MDR report key: 147432 · Received February 6, 1998

    Report

    Report Number
    2184002-1998-00075
    Event Type
    Injury
    Date Received
    February 6, 1998
    Date of Event
    October 11, 1997
    Report Date
    February 5, 1998
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    5 IMPLANTS PLACED 7/1997. 2 WERE REMOVED 10/11/1997. ONE PERSON AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 4X13 SELF-TAP Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. R9010-40-13 75971246

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention