BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLACKSTONE ICON SPINAL FIXATION SYSTEM

    MDR report key: 1013318 · Received March 12, 2008

    Report

    Report Number
    1225457-2008-00003
    Event Type
    Injury
    Date Received
    March 12, 2008
    Manufacturer
    BLACKSTONE MEDICAL, INC.
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT # 014, 021.

    Description of Event or Problem · 1

    PATIENT FELL 9 MONTHS AFTER ORIGINAL SURGERY ONE SIDE OF CONSTRUCT LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLACKSTONE ICON SPINAL FIXATION SYSTEM SET SCREW KWQ BLACKSTONE MEDICAL, INC. 54-2001 011

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention