BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SDI THREADED FUSION CAGE

    MDR report key: 113776 · Received August 15, 1997

    Report

    Report Number
    1219161-1997-01042
    Event Type
    Injury
    Date Received
    August 15, 1997
    Date of Event
    July 18, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    MAX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT WAS IMPLANTED ON APRIL 21, 1997. REPORTEDLY, THE PT EXPERIENCED PAIN AND NUMBNESS IN HER THIGHS AND LEGS POST-OPERATIVELY. THE SURGEON PERFORMED A REOPERATION ON JULY 18,1997 TO REMOVE THE CAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SDI THREADED FUSION CAGE Implant INTERBODY FUSION DEVICE MAX UNITED STATES SURGICAL CORP. NA K7C28

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention