BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICON MODULAR SPINAL FIXATION SYSTEM

    MDR report key: 1023426 · Received April 2, 2008

    Report

    Report Number
    1225457-2008-00008
    Event Type
    Injury
    Date Received
    April 2, 2008
    Date of Event
    December 10, 2007
    Report Date
    April 2, 2008
    Manufacturer
    BLACKSTONE MEDICAL, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K042514
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO MFR; NO EVAL COULD BE PERFORMED.

    Description of Event or Problem · 1

    IN 2007 PT UNDERWENT SURGERY TO IMPLANT SPINAL HARDWARE. ABOUT 2 MONTHS LATER, A REVISION SURGERY WAS PERFORMED BECAUSE THE ROD HAD "SLID OUT OF THE HOLDER ON THE LEFT SIDE." ONE MONTH LATER, A SECOND REVISION SURGERY WAS PERFORMED TO REPLACE THE HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICON MODULAR SPINAL FIXATION SYSTEM SPINAL PEDICLE FIXATION KWQ BLACKSTONE MEDICAL, INC. 54-2050 D02

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention