BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE 5X10 SEF-TAP+

    MDR report key: 101028 · Received June 28, 1997

    Report

    Report Number
    2184002-1997-00241
    Event Type
    Injury
    Date Received
    June 28, 1997
    Date of Event
    May 29, 1997
    Report Date
    June 27, 1997
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IMPLANT WAS PLACED 5/14/97. IT WAS REMOVED 5/29/97 DUE TO INFECTION. ONE PERSON AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE 5X10 SEF-TAP+ Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. R9010-50-10 75960232

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention