BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEQUOIA TI POLY SCREW ASSY 6.5MM X 45MM

    MDR report key: 1253069 · Received December 5, 2008

    Report

    Report Number
    1649384-2008-00596
    Event Type
    Injury
    Date Received
    December 5, 2008
    Date of Event
    November 10, 2008
    Report Date
    November 24, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS PENDING UPON THE PRODUCT INVESTIGATION.

    Description of Event or Problem · 1

    IN 2008, THE SALES REPRESENTATIVE REPORTED THAT DURING SURGERY THE SCREW THREADS STRIPPED. ADDITIONAL INFORMATION RECEIVED VIA TELEPHONE ON 20 NOV 2008, THE SALES REPRESENTATIVE REPORTED THAT THE THREADS STRIPPED AWAY IN THE HEAD OF THE SCREW. THE SURGEON HAD IMPLANTED TWO CLOSURE TOPS ON THE SAME SCREW AND THEN EXPLANTED THE CLOSURE TOPS, THE ROD, AND THE SCREW. THE SURGEON IMPLANTED A NEW SCREW AND REIMPLANTED THE REST OF THE CONSTRUCT. THERE WAS A SURGICAL DELAY OF 10 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEQUOIA TI POLY SCREW ASSY 6.5MM X 45MM SEQUOIA KWP ABBOTT SPINE 52FY

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention