BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL FIXATION SYSTEM, ICON MODULAR FIXATION

    MDR report key: 830257 · Received March 19, 2007

    Report

    Report Number
    1225457-2007-00003
    Event Type
    Injury
    Date Received
    March 19, 2007
    Report Date
    March 19, 2007
    Manufacturer
    BLACKSTONE MEDICAL, INC.
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MODEL # 56-2001, LOT #'S 026,B42, B165.

    Description of Event or Problem · 1

    A 3-LEVEL FUSION, L4-S1 WAS PERFORMED WITH BLACKSTONE MEDICAL, INC. SFS MONO-AXIAL AND ICON MODULAR SCREWS. THE PT WAS REVISED TWICE. 8 WEEKS POST-OP, TWO SFS SET SCREWS WERE REMOVED DUE TO LOOSENING WITH NO CLEAR DYSFUNCTION. AFTER 6 WEEKS, ALL IMPLANTS WERE REMOVED DUE TO CONSTRUCT LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL FIXATION SYSTEM, ICON MODULAR FIXATION SET SCREWS KWQ BLACKSTONE MEDICAL, INC. 54-2001 018

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention