BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHAMELEON FACETFUSE MIS SCREW SYSTEM

    MDR report key: 1757121 · Received June 17, 2010

    Report

    Report Number
    3005977257-2010-00002
    Event Type
    Malfunction
    Date Received
    June 17, 2010
    Date of Event
    May 24, 2010
    Report Date
    June 17, 2010
    Manufacturer
    SPINEFRONTIER, INC.
    Product Code
    MRW
    PMA / PMN Number
    K071420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST HAS BEEN MADE TO PROVIDE FILMS AND THE ACTUAL DEVICE FROM THE PROCEDURE. WAITING FOR THE DEVICE TO PERFORM AN EVALUATION AND DETERMINE ROOT CAUSE. THE PRODUCT'S LOT AND SIMILAR PRODUCT HAVE BEEN EVALUATED AND NO IRREGULARITIES HAVE BEEN FOUND. LOT HISTORY RECORDS HAVE BEEN REVIEWED AND FOUND TO MEET QUALITY REQUIREMENTS.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT DURING INSERTION OF THE SCREW THE HEAD OF THE SCREW SHEARED FROM THE SHAFT. THE SURGERY TIME WAS EXTENDED BY APPROX 2 MINUTES. THERE WAS NO REPORT OF PT INJURY. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE FIXATION DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHAMELEON FACETFUSE MIS SCREW SYSTEM MRW SPINEFRONTIER, INC. IM0045 W19658/1

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other