BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEQUOIA

    MDR report key: 1002556 · Received February 26, 2008

    Report

    Report Number
    1649384-2008-00081
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    January 31, 2008
    Report Date
    February 26, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    KWP
    Removal / Correction Number
    1649384-02/13/2008-001-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE DEVICE HISTORY RECORD REVIEW INDICATE THE PART MET SPECIFICATION. VISUAL EXAMINATION OF THE RETURNED SCREW INDICATES THE TULIP HEAD IS DISSOCIATED FROM THE SHAFT. THE SEQUOIA SCREWS WERE RECALLED ON 02/13/2008 AND THE OFFICE RECALL AND EMERGENCY COORDINATOR WAS NOTIFIED OF THE ACTIONS TAKEN ON 02/19/2008. FURTHER INVESTIGATION IS PENDING.

    Description of Event or Problem · 1

    IN 2008 VIA TELEPHONE, THE SALES REPRESENTATIVE REPORTED THAT THE SURGEON THOUGHT THE L5 LEFT SCREW MIGHT BE LOOSE AFTER THE SEQUOIA CONSTRUCT WAS IMPLANTED. THE SURGEON REMOVED THE CLOSURE TOP AND ROD, AND CLAMPED THE TULIP HEAD ON THE SIDE WITH A KOCHER FORCEP. THE TULIP HEAD DISASSEMBLED FROM THE SCREW SHAFT. THE SCREW WAS REMOVED AND REPLACED WITH ANOTHER SCREW, INCURRING APPROXIMATELY A 5 MINUTE SURGICAL DELAY. THE SALES REPRESENTATIVE INDICATED THE SCREW WAS AT AN EXTREME ANGLE WHEN INITIALLY IMPLANTED AND SECURED TO THE ROD. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEQUOIA POLYAXIAL PEDICLE SCREW KWP ABBOTT SPINE 47WN

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention