BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 5052440 · Received September 3, 2015

    Doing adverse event research by hand?

    The Research Assistant searches MAUDE for you, groups reports by failure mode, and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Report

    Report Number
    1030489-2015-02188
    Event Type
    Injury
    Date Received
    September 3, 2015
    Report Date
    August 6, 2015
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). PMA 510(K): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 1476000500, 510K # K091974 WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT PLIF SURGERY AT T9-S2-ILIAC FOR TREATING KYPHOSIS AFTER PSEUDARTHROSIS. POST-OP, RODS ON THE BOTH SIDE AROUND L1-3 LEVELS (NO SCREWS AT L2) WERE BROKEN. BROKEN RODS WERE REPLACED WITH 4 RODS CONSTRUCT. THE SURGEON TOLD THAT 4.75(FIX TYPE) SPINAL SYSTEM WAS CHOSEN DUE TO SKINNY TYPE BUT IT COULD NOT BEAR THE WEIGHT. THE SURGEON REMOVED HOOK AND ROD AT TH9 AND INSERTED A NEW ROD AT TH10-S2-IL. HE CONNECTED RODS ON BOTH SIDES WITH CONNECTORS AND TIGHTENED BY 4 ROD CONSTRUCT. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583769 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention