BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 4356866 · Received December 23, 2014

    Report

    Report Number
    1030489-2014-04839
    Event Type
    Injury
    Date Received
    December 23, 2014
    Date of Event
    November 27, 2014
    Report Date
    November 27, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10.
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). PMA 510(K). THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE CATALOG # 8590855 AND 510K # K981676 OF A 'LIKE DEVICE' WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PEDIATRIC PATIENT WITH SCOLIOSIS UNDERWENT AN ANTERIOR FUSION AT T11-L3. AN X-RAY TAKEN IMMEDIATELY POST-OP AFTER INCISION CLOSURE SHOWED THAT ONE OF THE SET SCREWS HAD NOT BROKEN OFF. THE SURGEON RE-OPENED THE INCISION AND BROKE IT OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO OTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846804 CD HORIZON® SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00012 YR Required Intervention