BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6783834 · Received August 10, 2017

    Report

    Report Number
    1030489-2017-01900
    Event Type
    Injury
    Date Received
    August 10, 2017
    Report Date
    July 19, 2017
    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

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 1606200500, 510K # K131321 AND (B)(4) WAS CLEARED IN THE UNITED STATES. (REVISION SURGERY, POOR ALIGNMENT). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS PREOPERATIVELY DIAGNOSED WITH KYPHOSIS, AND UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION (PLIF) AT LEVELS T10/S2AI. POST-OP, THE RODS BROKE DUE TO WHICH THE PATIENT HAD "POOR ALIGNMENT". HENCE, THE PATIENT UNDERWENT A REVISION SURGERY, IN WHICH THE RODS WERE REPLACED, SCREWS WERE ADDED AND CONSTRUCTING 4-RODS FIXATION WAS PERFORMED. NO FRAGMENT OF THE BROKEN RODS REMAINED INSIDE THE PATIENT. PATIENT OUTCOME AFTER THE REVISION SURGERY IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565455 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention