BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCOMPASS

    MDR report key: 865552 · Received June 15, 2007

    Report

    Report Number
    1649384-2007-00122
    Event Type
    Injury
    Date Received
    June 15, 2007
    Date of Event
    May 10, 2007
    Report Date
    June 15, 2007
    Manufacturer
    ABBOTT SPINE, INC.
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IN 2007, A SURGEON PERFORMED A REVISION SURGERY TO REMOVE A DISASSOCIATED CLOSURE TOP. DURING THE REMOVAL OF THE CLOSURE TOP, THE SURGEON ALSO REMOVED AND REPLACED THE INITIAL POLYAXIAL SCREW. THERE WAS A SURGICAL DELAY OF 30 MINS. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INCOMPASS 1/4 SS 6.5MM X 50MM FIXED ANGLE SCREW - OPEN KWQ ABBOTT SPINE, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention