BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 3120331 · Received May 20, 2013

    Report

    Report Number
    1030489-2013-01769
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 25, 2013
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    K113174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED SPINAL PROCEDURE FOR SCOLIOSIS. IT WAS REPORTED ¿THAT THE SURGEON REQUESTED A 60 ROD; A 55 ROD WAS IMPLANTED IN ERROR. BELIEVING THE ROD WAS A 60,1/4 INCH CROSSLINKS AND ILIAC CONNECTORS WERE USED IN THIS CONSTRUCT. THE SURGEON BROUGHT THE PATIENT BACK TO CONFIRM THE ROD SIZE AND ALSO TO ADJUST THE ALIGNMENT OF THE CONSTRUCT. DURING THE REALIGNMENT AND ROD VERIFICATION SURGERY THE 1/4 INCH CROSSLINKS AND ILLIAC CONNECTORS WERE REPLACED WITH 55 IMPLANTS.¿ NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222366 CD HORIZON® SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC. NA 02383020W

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR