BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 8840200 · Received July 30, 2019

    Report

    Report Number
    1030489-2019-00838
    Event Type
    Injury
    Date Received
    July 30, 2019
    Report Date
    July 30, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    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 # 55811015525, 510K #K122433 AND UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. 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. 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 CORRECTION AND FIXATION AT T4 TO TREAT ADOLESCENT IDIOPATHIC SCOLIOSIS. ON AN UNKNOWN DATE, POST-OP, THE SCREW IMPLANTED AT T4 UPPER LEVEL DEVIATED TO THE MEDIAL SIDE. PARALYSIS AND NEUROLOGICAL SYMPTOMS WERE ALSO REPORTED. HENCE, A REVISION SURGERY WAS PERFORMED, IN WHICH, THE DEVIATED SCREW WAS REMOVED AND PART OF THE ROD WAS CUT. THE OPERATION WAS THEN COMPLETED. PATIENT'S OUTCOME AFTER THE REVISION SURGERY WAS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635981 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention