BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9.5X80 POLYAXIAL SCREW

    MDR report key: 7445123 · Received April 19, 2018

    Report

    Report Number
    3005525032-2018-00026
    Event Type
    Malfunction
    Date Received
    April 19, 2018
    Date of Event
    March 21, 2018
    Report Date
    June 12, 2018
    Manufacturer
    STRYKER SPINE-US
    Product Code
    NKB
    UDI-DI
    07613327352047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    METHOD: VISUAL INSPECTION, DEVICE HISTORY REVIEW, COMPLAINT HISTORY REVIEW, RISK ASSESSMENT. RESULT: THE CUSTOMER REPORTED EVENT WAS CONFIRMED VIA VISUAL INSPECTION. THE SCREW WAS RETURNED IN 2 PIECES, WITH THE TULIP HEAD DISENGAGED FROM THE SCREW SHANK. THERE WAS DEFORMATION ON THE TULIP LOCKING RING AND THE HEAD OF THE SCREW SHANK. MANUFACTURING HISTORY WAS REVIEWED AND NO ISSUES WERE IDENTIFIED. CONCLUSION: THE DAMAGE SEEN TO THE LOCKING RING AND THE SCREW SHANK ARE INDICATIVE TO FORCE BEING APPLIED TO THE TULIP HEAD. DEFORMATION OF THE LOCKING RING WAS LOCALIZED TO ONE AREA, MEANING THE TULIP HEAD WAS MOST LIKELY ANGULATED IN THAT DIRECTION WHEN IT DISENGAGED. OVER ANGULATION AND EXCESSIVE FORCE APPLIED ARE POTENTIAL ROOT CAUSES FOR TULIP DISENGAGEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY, THE POLY-AXIAL PEDICLE SCREW TULIP HEAD DISENGAGED. IT WAS REMOVED AND REPLACE WITH THE SAME TYPE OF SCREW. ALL FRAGMENT WERE REMOVED. THERE WAS A REPORTED SURGICAL DELAY OF ONE HOUR. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT IN THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE POLY-AXIAL PEDICLE SCREW TULIP HEAD DISENGAGED. IT WAS REMOVED AND REPLACE WITH THE SAME TYPE OF SCREW. ALL FRAGMENT WERE REMOVED. THERE WAS A REPORTED SURGICAL DELAY OF ONE HOUR. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286746 9.5X80 POLYAXIAL SCREW THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB STRYKER SPINE-US 482619580 B73635 07613327352047

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR