BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTEX PEDICLE SCREW SYSTEM

    MDR report key: 2443839 · Received February 3, 2012

    Report

    Report Number
    3005031160-2012-00001
    Event Type
    Injury
    Date Received
    February 3, 2012
    Date of Event
    January 4, 2012
    Report Date
    January 6, 2012
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    MNH
    PMA / PMN Number
    K090224
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LUMBAR FUSION SURGERY. DATE OF INITIAL SURGERY: (B)(6) 2011. ACCORDING TO THE REPORTER: A PEDICLE SCREW BROKE POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORTEX PEDICLE SCREW SYSTEM PEDICLE SCREW SYSTEM MNH X-SPINE SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other