BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GSO

    MDR report key: 1411792 · Received July 2, 2009

    Report

    Report Number
    1411792
    Event Type
    Malfunction
    Date Received
    July 2, 2009
    Date of Event
    May 11, 2009
    Report Date
    July 1, 2009
    Manufacturer
    GOLD STANDARD ORTHOPEDICS
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US

    Narratives

    Description of Event or Problem · 1

    GSO 5 OUT OF 7 SET SCREWS STRIPPED. INSTRUMENTATION GSO UNABLE TO BE USED ON PATIENT. MALFUNCTION OF INSTRUMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GSO HARDWARE, ORTHOPEDIC, POSTERIOR LUMBAR FUSION KWQ GOLD STANDARD ORTHOPEDICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR