BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI 5.5 FLEXIBLE ANGLE SCREW 6.0X40

    MDR report key: 1171171 · Received September 22, 2008

    Report

    Report Number
    1649384-2008-00495
    Event Type
    Injury
    Date Received
    September 22, 2008
    Date of Event
    August 25, 2008
    Report Date
    September 22, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTS HAVE BEEN MADE FOR THE RETURN OF THE PRODUCT. REQUEST HAS BEEN MADE TO OBTAIN THE PRODUCT. EVALUATION IS PENDING UPON THE RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    ON THE EVENT DATE, THE SALES REPRESENTATIVE REPORTED THAT ABOUT ONE MONTH AGO, THE PT HAD UNDERGONE AN L2-L4 FUSION. ON AN UNKNOWN DATE, THE PT EXPERIENCED PAIN. ON THE SAME DAY, THE PT UNDERWENT A REVISION SURGERY FOR PAIN. WHEN THE DR REVISED THE PT, IT WAS IDENTIFIED THAT THE RIGHT SIDE ROD WAS OUT AND LOWER THAN THE L2 PEDICLE SCREW. THE ROD WAS CAPTURED BUT LOOSE IN THE WEDGES OF THE L3 AND L4 SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI 5.5 FLEXIBLE ANGLE SCREW 6.0X40 BACFIX TI KWP ABBOTT SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention