BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCOMPASS

    MDR report key: 865573 · Received June 15, 2007

    Report

    Report Number
    1649384-2007-00058
    Event Type
    Injury
    Date Received
    June 15, 2007
    Date of Event
    May 15, 2007
    Report Date
    June 13, 2007
    Manufacturer
    ABBOTT SPINE, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. THE INVESTIGATION OF THE PRODUCT WAS COMPLETED BY INSPECTING THE RETURNED DRIVER AND REVIEWING THE DEVICE HISTORY RECORD FOR THE LOT. THE PRODUCT MET SPECIFICATIONS. THE INVESTIGATION CONCLUDED THAT THE TIP OF THE INSTRUMENT IS BENT SUCH THAT IT DOES NOT ALLOW FOR IT TO MATE WITH THE INCOMPASS SCREW HEAD AND THUS, CONTRIBUTED TO THE SURGICAL DELAY. FURTHER INVESTIGATION IS PENDING FOR THIS ISSUE.

    Description of Event or Problem · 1

    IN 2007, A FEMALE PATIENT UNDERWENT THORACOLUMBAR SURGERY WITH THE INCOMPASS PRODUCT AND THE OPEN MODULAR TI SCREWDRIVER WOULD NOT SEAT ONTO THE SCREW. THIS ISSUE CAUSED A 30 MINUTE SURGICAL DELAY. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INCOMPASS OPEN SCREWDRIVER MODULAR TI LXH ABBOTT SPINE, INC. NA 34XN

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other