BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEQUOIA

    MDR report key: 1002801 · Received February 26, 2008

    Report

    Report Number
    1649384-2008-00077
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Date of Event
    January 29, 2008
    Report Date
    February 26, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    HXX
    Removal / Correction Number
    1649384-02/13/08-001-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE DEVICE HISTORY RECORD REVIEW INDICATES THE PART MET SPECIFICATION. VISUAL AND FUNCTIONAL EXAMINATION OF THE RETURNED PART INDICATES THE LEADING THREAD FORM IS DAMAGED AND INHIBITS THREADING ONTO THE TULIP HEAD. THE SEQUOIA DRIVERS WERE RECALLED ON 02/13/2008 AND THE OFFICE RECALL & EMERGENCY COORDINATOR WAS NOTIFIED OF THE ACTIONS TAKEN ON 02/19/2008. FURTHER INVESTIGATION IS PENDING.

    Description of Event or Problem · 1

    IN 2008, THE SALES REP REPORTED THAT DURING A THORACOLUMBAR PROCEDURE, THE DRIVER BROKE. ADDITIONAL INFORMATION RECEIVED ON 06 FEB, 2008, THE SALES REP REPORTED VIA TELEPHONE THAT TWO DRIVERS WOULD NOT ENGAGE THE TULIP HEAD. THE SURGEON WAS USING THE FIRST DRIVER, AND THE SCREW WOULD NOT ENGAGE THE TULIP HEAD AND ONCE IT DID, THE SURGEON COULD NOT DISENGAGE IT. THE SURGEON THEN USED PLIERS TO DISENGAGE THE DRIVER FROM THE TULIP HEAD. THE SURGEON USED THE SECOND DRIVER TO FINISH THE CASE. AFTER THE CASE WAS COMPLETED, THE SALES REP INSPECTED THE DRIVER AND NOTICED THAT BLACK SHAFT WAS DEFORMED. THE SURGERY EXTENSION WAS 15 MINUTES. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEQUOIA SEQUOIA MODULAR SCREWDRIVER HXX ABBOTT SPINE 47PY

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention