BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON - CHROMALOY PLUS ROD

    MDR report key: 10306924 · Received July 22, 2020

    Report

    Report Number
    1030489-2020-00950
    Event Type
    Malfunction
    Date Received
    July 22, 2020
    Date of Event
    July 3, 2020
    Report Date
    July 22, 2020
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    K111942
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR: (B)(6). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 1556000500, 510K # K111942, UPN 00613994789914 WAS CLEARED IN THE UNITED STATES. 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 PRODUCT USED TO TREAT SYMPTOMATIC SCOLIOSIS FOR SPINAL THERAPY. IT WAS REPORTED THAT, PRE OP, BOTH THE SET SCREWS JAMMED. BEFORE USE, THE SCRUB NURSE WAS ASKED TO PREPARE FOR THE PROCEDURE, THEN IT WAS NOTICED THAT THE SET SCREW WAS VERY STIFF, SO ANOTHER ONE WAS OPENED BUT IT HAD THE SAME MALFUNCTION. IT WAS FOUND THAT THESE TWO SET SCREWS HAVE SAME LOT#, SO THE THIRD ONE, FOR WHICH THE LOT#IS DIFFERENT, WAS OPENED. THERE WAS NO PROBLEM WITH THE OPERATION OF THIS SET SCREW, SO IT WAS USED ON THE OPERATIVE FIELD. THERE WAS NO PATIENT INVOLVED IN THE REPORTED EVENT. THE PRODUCTS WILL BE RETURNED AND WERE ALREADY REPLACED. PROCEDURE INVOLVED: AN OPERATION TO PLACE THE ROD AGAIN TO TREAT SYMPTOMATIC SCOLIOSIS. DEVICE STATUS: NEVER IMPLANTED ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT. IT WAS REPORTED THAT THIS OPERATION WAS A RE-OPERATION, THE ROD INSERTING ON ONE SIDE WAS BROKEN, SO THE RE-OPERATION WAS PERFORMED. THERE WAS NO INFORMATION RECEIVED SUCH AS NEUROLOGICAL SYMPTOM OCCURRED DUE TO THE BROKEN ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773604 CD HORIZON - CHROMALOY PLUS ROD APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS 1556100500 0240780W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention