BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SDI

    MDR report key: 280491 · Received June 1, 2000

    Report

    Report Number
    1219161-2000-00473
    Event Type
    Injury
    Date Received
    June 1, 2000
    Date of Event
    April 7, 2000
    Report Date
    May 2, 2000
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    LBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A PERCUTANEOUS DISKECTOMY. REPORTEDLY, THE TIP OF THE DEVICE BROKE AND DISENGAGED INTO THE PT'S DISK. THE SURGEON WAS ABLE TO LOCATE THE COMPONENT, PERFORMED RE-OPERATION, AND COMPLETED THE DISKECTOMY INVASIVELY. THE HOSP HAS REPORTED THE PT'S CONDITION IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SDI FLEX II NUCLEOTOME KIT LBK UNITED STATES SURGICAL CORP. NA K8L36

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention