BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3783574 · Received May 1, 2014

    Report

    Report Number
    1030489-2014-02385
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OPERATING ROOM : THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 8549305, 510K # K020709 WAS CLEARED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: VISUAL AND OPTICAL EXAMINATION OF THE RETURNED DOMINO SET SCREW IDENTIFIED DISPLACED MATERIAL MOVEMENT, WITH CIRCULAR WITNESS MARKS INSIDE OF THE HEX, AS WELL AS ROUNDED HEX CORNERS. THE DEFORMATION IS CONSISTENT DOWN THE FULL DEPTH OF THE IMPLANT, SUGGESTING FULL INSERTION OF THE DRIVER DURING USAGE. THE ABOVE FINDINGS ARE CONSISTENT WITH STRIPPING TORSIONAL OVERLOAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE WITH LENGTH GROWING RODS AT T2-L2. APPROXIMATELY ONE YEAR POST-OP, A SECOND SURGERY WAS PERFORMED TO LENGTHEN THE RODS; ADD SCREWS AT T2, T3, L1 AND L2 AND 2 DOMINOES WERE PLACED AROUND T6 AND T9. IT WAS REPORTED THAT ONE OF THE SET SCREWS STRIPPED ON THE DOMINO CONNECTOR. AN INCISION WAS MADE ON THE RIGHT SIDE TO REMOVE THE CAUDAL ROD THAT WAS CONNECTED TO THE IMMOVABLE CONNECTOR. NEW DOMINOES AND CONNECTORS WERE IMPLANTED AND THE SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262987 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0224096W

    Patients

    Seq Age Sex Outcome Treatment
    1 00009 YR Required Intervention RODS, BONE SCREWS