BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELOX ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 10182158 · Received June 22, 2020

    Report

    Report Number
    3004717358-2020-00002
    Event Type
    Malfunction
    Date Received
    June 22, 2020
    Date of Event
    June 1, 2020
    Report Date
    June 22, 2020
    Manufacturer
    SPINECRAFT
    Product Code
    KWQ
    UDI-DI
    00193082001086
    PMA / PMN Number
    K131521
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE DEVICE WAS NOT RETURNED FOR EVALUATION TO SPINECRAFT AND WAS DISCARDED BY THE HOSPITAL, THE EXACT LOT NUMBER OF THE DEVICE USED COULD NOT BE RETRIEVED. HOWEVER, BASED ON THE 5 LOT NUMBERS (110530, 110532, 113669, 187213 AND 91156) MANUFACTURED OF THE SAME SCREW SIZE THAT WERE IN THIS SPECIFIC KIT (ONE OF WHICH WAS USED IN THIS SURGERY), THE REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR APPLICABLE MATERIAL, MANUFACTURING PROCESSES, DESIGN SPECIFICATIONS AND INSPECTION RECORDS. NO DEVIATIONS OR DISCREPANCIES WERE FOUND. FURTHERMORE, THE USAGE HISTORY REVIEW FOR THESE 5 LOTS SHOWED THAT A TOTAL OF 367 SCREWS OUT OF THE 909 MANUFACTURED FROM THESE LOTS HAVE BEEN USED IN DIFFERENT SURGERIES WITHOUT ANY REPORTED ISSUES. ALSO, A GENERAL REVIEW OF THE USAGE HISTORY OF VELOX SYSTEM SCREWS AND COMPLAINT TREND ANALYSIS SHOWED THAT THOUSANDS OF THESE SCREWS HAVE BEEN USED IN SURGERIES SINCE THE LAUNCH OF THE SYSTEM IN 2014 AND NO SIMILAR ISSUES HAVE BEEN REPORTED TO DATE. BASED ON THE PRE-OPERATIVE (BEFORE THE REVISION SURGERY) X-RAY IMAGES PROVIDED, THE SCREW BACK OUT WAS CONFIRMED, HOWEVER, NO CONCLUSIONS COULD BE MADE. THE X-RAY IMAGE ALSO SHOWED THAT THE PLATE RING WAS INTACT AND HAD NO SIGNS OF DISLODGEMENT. SINCE SCREW BACK OUT IS A KNOWN RISK, NUMEROUS TESTING WERE PERFORMED DURING SYSTEM DEVELOPMENT TO ELIMINATE THIS FAILURE MODE AND ALL NECESSARY VERIFICATION / VALIDATION ACTIVITIES WERE COMPLETED BEFORE THE RELEASE OF VELOX SYSTEM TO CONFIRM THAT THIS FAILURE MODE WILL NOT OCCUR DURING CLINICAL USE. BASED ON THE ABOVE INFORMATION AND ABSENCE OF POST-OPERATIVE X-RAYS FROM THE ORIGINAL SURGERY, NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED AS NO ISSUE HAS BEEN IDENTIFIED WITH THE DESIGN, MANUFACTURING OR RELEASE OF ANY OF THE SCREW LOTS WHICH MAY HAVE BEEN USED IN SURGERY THAT COULD HAVE CONTRIBUTED TO PROBLEM REPORTED. IT CAN BE PRESUMED HOWEVER THAT THE SCREW BACK OUT OCCURRED DUE TO THE FACT THAT THE SCREW MAY NOT HAVE BEEN FULLY INSERTED INTO THE PLATE LOCKING RING CAUSING INCOMPLETE LOCKING OF THE SCREW. THIS INCOMPLETE INSERTION MAY HAVE BEEN DUE TO THE FOLLOWING KNOWN AND IDENTIFIED RISKS: INSUFFICIENT TORQUE APPLICATION, EXTREME ANGULATION OF SCREW BEYOND WHAT THE PLATE DESIGN ALLOWS OR A NON-CENTERED DRILLED HOLE IF THE DRILL GUIDE WAS NOT USED.

    Description of Event or Problem · 1

    APPROXIMATELY 3.5 MONTHS POST-OPERATIVELY AFTER A PERIODIC PATIENT FOLLOW-UP, THE X-RAY IMAGES REVEALED THAT ONE (1) VELOX SCREW HAD BACKED OUT BY A FEW MILLIMETERS FROM THE PLATE. THERE WERE NO CLINICAL SYMPTOMS REPORTED BY THE PATIENT; HOWEVER, THE SURGEON DECIDED TO PERFORM A REVISION SURGERY TO REPLACE THIS SCREW. WHEN THE SURGERY WAS PERFORMED, THE SURGEON CONFIRMED THAT THE PLATE RING HOLDING THE SCREW IN QUESTION WAS INTACT AND THE SURGERY WAS COMPLETED AS INTENDED WITH NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642459 VELOX ANTERIOR CERVICAL PLATE SYSTEM SCREW KWQ SPINECRAFT VVS2-4012 00193082001086

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention