BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 7240874 · Received February 5, 2018

    Report

    Report Number
    1030489-2018-00163
    Event Type
    Injury
    Date Received
    February 5, 2018
    Date of Event
    January 17, 2018
    Report Date
    February 5, 2018
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    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 # 6958724; UDI# (B)(4); 510K # K083071 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT POSTERIOR CERVICAL SPINAL FUSION SURGERY AT C5. POST-OP, NEXT DAY EVENING, NEUROLOGICAL SYMPTOM OCCURRED TO THE PATIENT. ALTHOUGH THE DIRECT REASON OF NEUROLOGICAL SYMPTOM WAS DIAGNOSED AS HEMATOMA, IT WAS REPORTED THAT THE SCREW WAS MALPOSITIONED THAT CAUSED RUPTURE OF MEDIAL SIDE OF THE PEDICLE. THE EXTRACTION SURGERY WAS DECIDED TO BE PERFORMED TO REMOVE THE SCREW. ALTHOUGH MEDIAL RUPTURE WAS NOT THE DIRECT REASON OF NEUROLOGICAL SYMPTOM, IT WAS SAID THAT PEDICLE SCREW WAS DECIDED TO BE REMOVED AS WELL SINCE IT WAS NECESSARY TO REMOVE THE HEMATOMA. THE UNILATERAL FUSION WAS PERFORMED WITH PEDICLE SCREW (PS) AT C5 AND LATERAL MASS SCREW (LMS) AT C6 ONLY ON THE RIGHT SIDE DURING INITIAL SURGERY. DURING REVISION SURGERY, PEDICLE SCREW WHICH WAS INSERTED AT C5 WAS REMOVED. LATERAL MASS SCREW WAS ADDED TO BE INSERTED AT C4 AND RE-FIXATION WAS PERFORMED AT C4-6 AFTER REMOVING THE HEMATOMA AND PERFORMING BONE GRAFT. ACCORDING TO THE HEALTHCARE PROFESSIONAL'S OPINION, THE REPORTED EVENT IS NOT RELATED TO USE OF MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86058 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention