BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON - LINED CHROMALOY PLUS ROD

    MDR report key: 10312711 · Received July 23, 2020

    Report

    Report Number
    1030489-2020-00960
    Event Type
    Malfunction
    Date Received
    July 23, 2020
    Date of Event
    October 3, 2014
    Report Date
    July 23, 2020
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWQ
    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

    REPORT SOURCE: (B)(6). PMA/510K: THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 1556000500, 510K # K111942, UPN (B)(4) 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 PATIENT IMPLANTED WITH A ROD IN A PSF PROCEDURE FOR A SPINAL THERAPY. IT WAS REPORTED THAT THERE WAS ROD BREAKAGE BETWEEN RIGHT L5/S. IT WAS PLANNED TO ADDITIONALLY PLACE DUAL ROD ON THE RIGHT SIDE. RE-OPERATION WAS SCHEDULED FOR (B)(6) 2020. THE INITIAL OPERATION WAS PERFORMED ON (B)(6) 2014. A RE-OPERATION WAS PERFORMED ON (B)(6) 2016. BECAUSE THE SALES REP IS NOT THE PERSON IN CHARGE FOR THIS FACILITY, IT IS NOT SURE IF THE REASON FOR THE PREVIOUS OPERATIONS WERE LEFT ROD BREAKAGE AND ADDITIONAL PLIF, THE DETAILS ARE UNKNOWN. THIS TIME RE-OPERATION WAS PERFORMED DUE TO THAT THE RIGHT ROD WAS BROKEN. THE PATIENT ISSUE HAS NOT YET BEEN RESOLVED. THE REMOVED PRODUCT WILL BE RETURNED TO THE PATIENT. UPDATE: THE REVISION SURGERY WAS PERFORMED SUCCESSFULLY THE LIST OF PRODUCTS USED ARE ATTACHED. FOR THE DUAL ROD, THE LOT NUMBER IS SAME AS THE RIGHT ROD. IT WAS CUT FROM THE ROD 50 CM. THE SALES REP WAS REQUESTED FOR HELP ON THE OPERATION DAY. THE SALES REP SAID TO THE DOCTOR THAT THERE WAS A POSSIBILITY OF BREAKAGE OF LEFT X10 BEFORE THE PROCEDURE, SO THE PROCEDURE WAS CHANGED FROM PLANNING RIGHT SIDE DEPLOYMENT ONLY TO THE DEPLOYMENT ON BOTH SIDES. FORTUNATELY, THE LEFT CONNECTOR WAS NOT BROKEN, BUT THERE WAS A STATE OF METALLOSIS (DARKENING OF THE TISSUE), AND THE SCREW ON THE INNER SIDE OF X10 AT THE BOTTOM WAS LOOSENED. IT WAS RE-TIGHTENED TO COPE WITH THE PROBLEM. THE PIG NOSE SET SCREW WAS LOOSENED AND THE SET SCREWS AT S1 AND S2 WERE REMOVED. THE SCREW HEAD OF S1 AND S2 WERE ADJUSTED SLIGHTLY, IT WAS ADJUSTED TO BE IN A LINE. THE SAME ROD WAS CLEANED AND REUSED AT S1 AND S2. DIAMETER 5.5 CO-CR 50CM WAS CUT TO 10CM. IT WAS THOUGHT THAT IT WAS BETTER FOR THE LEFT AND RIGHT TO BE THE SAME, SO FOUR X10 16F WERE USED. IT TOOK TIME TO PLACE FOUR CONNECTORS, BUT THE OPERATION WAS COMPLETED AS PLANNED AT THE MINIMUM. ABOUT ONE YEAR AGO, ROD BREAKAGE HAD BEEN NOTED, BUT THE PATIENT HAD BEEN TREATED CONSERVATIVELY DUE TO THAT THE PATIENT HAD NO ANY SYMPTOMS. THE PATIENT WAS SUGGESTED TO PERFORM THE OPERATION ON THE LOWER BACK TOGETHER AS SHE WOULD HAVE SURGERY FOR LEG BONE FRACTURE. SO THE OPERATION THIS TIME WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777634 CD HORIZON - LINED CHROMALOY PLUS ROD APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDICS 1556300500 0415464W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention