BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCORPIO NRG INSERT TRIAL #7 12MM

    MDR report key: 1070406 · Received June 30, 2008

    Report

    Report Number
    2249697-2008-00186
    Event Type
    Malfunction
    Date Received
    June 30, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 9, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF DEVICE BECOMES AVAILABLE WITH ADD'L INFO, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING THE SURGERY, THE SCORPIO NRG INSERT TRIAL WAS CRACKED, WHEN THE SURGEON WAS INSERTING IT ONTO THE TIBIAL BASE PLATE". THE SURGEON REMOVED THE FRAGMENT OF THE TRIAL FROM THE PATIENT'S BODY. THE PATIENT DID NOT RECEIVE ANY HEALTH DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO NRG INSERT TRIAL #7 12MM INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other