BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 9128701 · Received September 27, 2019

    Report

    Report Number
    1030489-2019-01079
    Event Type
    Malfunction
    Date Received
    September 27, 2019
    Date of Event
    August 28, 2019
    Report Date
    December 23, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    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 #: 55811017545, 510K #: K122433 AND UDI #: (B)(4). WAS CLEARED IN THE UNITED STATES. PRODUCT WAS NOT 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.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE SCREW WAS FUNCTIONALLY TESTED AND APPEARS CAPABLE OF DOING ITS JOB. 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 PRESENTED WITH L2 BURST FRACTURE; AND UNDERWENT POSTERIOR FIXATION AT L1-L3. INTRA-OP, AFTER PERFORMING REDUCTION WITH TRAUMA DEVICE, WHEN THE SURGEON ATTEMPTED TO PERFORM FINAL TIGHTENING OF THE SET SCREW, THE SET SCREW ON THE LEFT OF L3 IDLED. EVEN WHEN THE SURGEON REPLACED THE SET SCREWS AND CHANGED ROD BENDING, ALL THE OTHER SCREWS IDLED TOO. THEN, THE SCREW WAS REMOVED AND WAS REPLACED WITH ANOTHER SCREW, AND ANOTHER ROD WAS INSERTED. FINAL TIGHTENING COULD THEN BE PERFORMED WITHOUT ANY PROBLEM. ALTHOUGH THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME DUE TO THIS EVENT, NO PATIENT COMPLICATIONS WERE REPORTED. WHEN THE REMOVED SCREW WAS AND EXTENDER ASSEMBLY WAS CHECKED, IT WAS FOUND THAT ONE SIDE OF THE EXTENDER DISPLACED FROM THE SCREW AND WAS OPEN. THIS COULD HAVE CAUSED THE SET SCREWS TO CROSS THREADED. THERE WAS NO ABNORMALITY IN APPEARANCE NOTED FOR THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922596 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC NA CA18C062

    Patients

    Seq Age Sex Outcome Treatment
    1