BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON LEGACY MINI SPINAL SYSTEM

    MDR report key: 2437965 · Received February 3, 2012

    Report

    Report Number
    1030489-2012-00126
    Event Type
    Malfunction
    Date Received
    February 3, 2012
    Date of Event
    October 25, 2011
    Report Date
    January 18, 2012
    Manufacturer
    WARSAW ORTHOPEDICS, INC.
    Product Code
    MNI
    PMA / PMN Number
    K042962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7343420, PRODUCT CODE MNI WAS CLEARED IN THE UNITED STATES. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7343420, 510K # K042962 WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE. AT THE END OF THE PROCEDURE, DURING COMPRESSION OF THE SCREW, IT WAS NOTICED THAT THE SCREW WAS LOOSE AND MOVED INTO THE PEDICLE. THE SCREW WAS REPLACED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON LEGACY MINI SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION MNI WARSAW ORTHOPEDICS, INC. 0062204W

    Patients

    Seq Age Sex Outcome Treatment
    1