BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 11892137 · Received May 27, 2021

    Report

    Report Number
    1030489-2021-00704
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    May 8, 2021
    Report Date
    May 27, 2021
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A SIMILAR DEVICE WITH PRODUCT ID X0409391 AND 510K #K981676 WAS MARKETED IN THE UNITED STATES. NEITHER THE DEVICE NOR ANY IMAGES 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

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A FIELD CONTACT REGARDING A PATIENT UNDERGOING A REVISION SURGERY DUE TO PJK AFTER A SPINAL THERAPY. IT WAS REPORTED THAT THE SET SCREW CAME OFF. THE SET SCREW WAS REPLACED, 3 RODS WERE PLACED ADDITIONALLY. THE PATIENT ISSUE WAS RESOLVED. THERE WERE NO FURTHER PATIENT SYMPTOMS/COMPLICATIONS. INITIAL REPORTER INFORMATION AND PATIENT INFORMATION CANNOT BE PROVIDED DUE TO THE RESTRICTION BY THE PRIVACY REGULATION. LEVELS IMPLANTED: T8-T10 MDT PRODUCTS USED IN INITIAL SURGERY: S4 IT WAS A CASE THAT EXTENSION OPERATION WAS PERFORMED ON (B)(6) 2018 (SOLERA 4.75 CONNECTED TO EACH OTHER). THE OPEN SIDE SET SCREW OF THE REPORTED MRC USED BETWEEN TH8 / 10 BACKED OUT. IT WAS UNKNOWN WHETHER BONE FUSION HAD ACHIEVED OR NOT. THIS TIME, THE SET SCREW THAT HAD BACKED OUT WAS DISCARDED, THE MRC WAS CONTINUED TO BE USED AS IT WAS, AND ONLY THE SET SCREW WAS REPLACED. IT WAS REINFORCED WITH 2 RODS ON THE SIDE THAT THE SET SCREW BACKED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794758 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS 778315555 0634564W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention