BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON MODULAR FIXATION SYSTEM

    MDR report key: 911129 · Received September 11, 2007

    Report

    Report Number
    1225457-2007-00018
    Event Type
    Malfunction
    Date Received
    September 11, 2007
    Report Date
    September 7, 2007
    Manufacturer
    BLACKSTONE MEDICAL, INC.
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD OF EVALUATION: PRODUCT, REVISION DETAILS, OR LOT INFORMATION FOR DEVICES HAVE NOT BEEN PROVIDED TO BLACKSTONE MEDICAL, INC. FOR EVALUATION.

    Description of Event or Problem · 1

    A CONSTRUCT DISENGAGEMENT WITH POSSIBLE REVISION WAS REPORTED TO BMI QUALITY ASSURANCE ON 8/9/07. ADDITIONAL INFORMATION, INCLUDING SPECIFIC CONSTRUCT COMPONENT DISENGAGEMENT, HAS NOT BEEN RECEIVED FROM THE REPORTING DISTRIBUTOR OR SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICON MODULAR FIXATION SYSTEM SPINAL FIXATION IMPLANT SYSTEM KWQ BLACKSTONE MEDICAL, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR