BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUSTAIN 3.3X13 HA SCREW IMPLANT

    MDR report key: 172018 · Received June 12, 1998

    Report

    Report Number
    2184002-1998-00409
    Event Type
    Injury
    Date Received
    June 12, 1998
    Date of Event
    May 28, 1997
    Report Date
    June 12, 1998
    Manufacturer
    LIFECORE BIOMEDICAL, INC.
    Product Code
    DZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT MEDICAL HISTORY WAS RECEIVED AND EVALUATED. INFECTION REMAINS THE PROBABLE CAUSE OF FAILURE.

    Description of Event or Problem · 1

    IMPLANT PLACED 3/25/1997. IT WAS REMOVED 5/28/1997 DUE TO INFECTION AT THE SITE. PT IS A NON-SMOKER AND IN GENERAL GOOD HEALTH. ONE PERSON AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUSTAIN 3.3X13 HA SCREW IMPLANT Implant ENDOSSEOUS IMPLANT DZE LIFECORE BIOMEDICAL, INC. 410040-33-13 75960550

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention