BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEQUOIA

    MDR report key: 1011662 · Received March 10, 2008

    Report

    Report Number
    1649384-2008-00130
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    February 12, 2008
    Report Date
    March 10, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    HXX
    Removal / Correction Number
    1649384-02/13/08-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. REQUESTS HAVE BEEN MADE FOR THE RETURN OF THE PRODUCT. REQUEST HAS BEEN MADE TO OBTAIN THE PRODUCT. DEVICE MANUFACTURE DATE IS UNKNOWN. THE SEQUOIA SCREWDRIVER WERE RECALLED ON 02/13/2008 AND THE DISTRICT 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 REPRESENTATIVE REPORTED THAT DURING A THORACOLUMBAR PROCEDURE, THE DRIVERS BROKE. ADDITIONAL INFORMATION RECEIVED ON 19 FEB, 2008. THE REGIONAL MANAGER REPORTED THAT THE SURGEON WAS DOING A REVISION SURGERY FOR AN UNKNOWN REASON. THE SURGEON EXPLANTED THE SMALLER DIAMETER SCREW AND IMPLANTED A SEQUOIA SCREW WHICH IS LARGER IN DIAMETER, AND THE SURGEON DID NOT TAP THE AREA BEFORE PLACING THE SCREW. THE SURGEON HIT CORTICLE BONE, AND HE WAS APPLYING DOWNWARD PRESSURE AND TORQUING THE DRIVER WHEN IT BROKE. THE SURGEON THEN ASKED FOR ANOTHER ONE AND THE SAME THING HAPPEN. THIS HAPPENED WITH A TOTAL OF THREE DRIVERS. THERE WAS NO REPORT OF SURGICAL DELAY OR PATIENT INJURY. THIS MALFUNCTION HAS RESULTED IN AN ADVERSE EVENT IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEQUOIA SQUOIA SCREWDRIVER MODULAR HXX ABBOTT SPINE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1