BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 10500866 · Received September 8, 2020

    Report

    Report Number
    1030489-2020-01221
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Date of Event
    July 27, 2020
    Report Date
    September 8, 2020
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    510(K) FOR SIMILAR PRODUCT MARKETED IN US WITH CATALOGUE # 1476200500 IS K132111. EVALUATION OF THE RETURNED DEVICE WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETE. 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 PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS OF TRAUMATIC VERTEBRAL FRACTURE (3 VERTEBRAL BODIES OF L1.L2.L5). IT WAS REPORTED THAT AFTER THE PROCEDURE THE SET SCREWS ON BOTH SIDES OF THE FIXED LOWER LEVEL(S2)HAD LOOSENED, ACCORDING TO THE IMAGE, THE ROD HAD MOVED. PRODUCT REMAINS IMPLANTED IN PATIENT.THE LOOSENING WAS SUSPECTED AND CONFIRMED ON JULY 27.IT WAS VERY PROBABLY THAT IT OCCURRED IMMEDIATELY AFTER WALKING AND SITTING ON THE BED WERE ALLOWED AT ABOUT 2 WEEKS AFTER OPERATION.THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. BONE GRAFT HAD NOT BEEN PERFORMED BECAUSE IT WAS A TRAUMA, AND PS WAS NOT INSERTED IN S1, AND BALLAST HAD BEEN INSERTED IN S2AI. INS TRUMENTATIONS WERE TH10,11,12,L1,2,3,4 AND 5, ANCHOR HAD BEEN INSERTED IN S2AI, AND BONE GRAFT HAD ONLY BEEN PERFORMED AT L1,2,3. AN ADDITIONAL OPERATION WAS PERFORMED ON AUGUST 5.THE BACKING OUT AND LOOSE OF THE SET SCREW OCCURRED, BUT IT WAS UNKNOWN WHETHER THE EVENT WAS CAUSED BY SCREW OR SET SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966868 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS 1556300500 0718992W

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention