BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX-HYBRID 1 LEVEL ACP SIZE 16MM

    MDR report key: 3232072 · Received July 17, 2013

    Report

    Report Number
    0009617544-2013-00267
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    KWQ
    PMA / PMN Number
    K040261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL REPORT. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE IDENTIFICATION; DEVICE HISTORY REVIEW; DEVICE INSPECTION; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT. RESULTS: THE RETURNED DEVICE WAS CONFIRMED TO BE A REFLEX HYBRID ONE LEVEL ANTERIOR CERVICAL 16MM PLATE (CAT. # 48651116), AND NO ANOMALIES WERE DETECTED WHEN THE DEVICE WAS VISUALLY AND FUNCTIONALLY INSPECTED. IT WAS REPORTED THAT DURING THE INSERTION OF THE FOURTH AND FINAL FIXED SELF-DRILLING SCREW INTO THE 16MM REFLEX HYBRID ONE LEVEL ACP PLATE, THE SCREW WENT THROUGH THE GOLD LOCKING RING AND BECAME ENCLOSED UNDER THE LOCKING RING. THERE WAS A SURGICAL DELAY OF 15 MINUTES AS A RESULT OF THE REPORTED EVENT. HOWEVER, NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED. IT WAS CONFIRMED THAT THE SURGERY WAS SUCCESSFULLY COMPLETED. THE SURGICAL TECHNIQUE STATES THAT PROPER ALIGNMENT AND DOWNWARD PRESSURE WILL ENSURE THE LOCKING RING IS EXPANDED AND WILL ALLOW THE BONE SCREW TO PASS THROUGH THE LOCKING RING. THE ESSENTIAL FUNCTION OF THE LOCKING RING IS TO ENSURE THE LOCKING OF THE SCREW AND SECURE IT IN PLACE. THEREFORE , THE SCREW IS INTENDED TO GO THROUGH THE LOCKING RING AND REMAIN ENCLOSED BY THE LOCKING RING. CONSEQUENTLY, NO ISSUE WAS IDENTIFIED AS DESCRIBED IN THE REPORTED EVENT AND A FAILURE MODE WAS NOT CONFIRMED. CONCLUSION: AS STATED IN THE SURGICAL TECHNIQUE, THE SCREW IS INTENDED TO GO THROUGH THE LOCKING RING AND REMAIN ENCLOSED BY THE LOCKING RING. CONSEQUENTLY, NO ISSUE WAS IDENTIFIED AS DESCRIBED IN THE REPORTED EVENT AND A FAILURE MODE WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS SURGEON IMPLANTED 16MM REFLEX HYBRID PLATE ON 4TH AND FINAL SCREW DRIVE THROUGH THE GOLD LOCKING RING AND HAD TO REMOVE 3 SCREWS, THEN PLATE, THEN THE 4TH SCREW. USED ANOTHER IMPLANT WITH RESCUE SCREW. NO ADVERSE REACTION TO PATIENT WAS ENCOUNTERED. CASE WAS DELAYED FOR ABOUT 15 MINUTES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS SURGEON IMPLANTED 16MM REFLEX HYBRID PLATE ON 4TH AND FINAL SCREW DRIVE THROUGH THE GOLD LOCKING RING AND HAD TO REMOVE 3 SCREWS, THEN PLATE, THEN THE 4TH SCREW. USED ANOTHER IMPLANT WITH RESCUE SCREW. NO ADVERSE REACTION TO PATIENT WAS ENCOUNTERED. CASE WAS DELAYED FOR ABOUT 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330472 REFLEX-HYBRID 1 LEVEL ACP SIZE 16MM IMPLANT KWQ STRYKER SPINE-FRANCE 10D050

    Patients

    Seq Age Sex Outcome Treatment
    1