BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TLIF CAGE DEVICE

    MDR report key: 2971087 · Received February 15, 2013

    Report

    Report Number
    2032593-2013-00009
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    SEASPINE, INC.
    Product Code
    MAX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    RECEIVED NOTICE OF INTENT TO FILE ACTION FOR DAMAGES ARISING FROM INJURIES FROM CUSTOMER WHICH NOTED: "OFF LABEL USE BY THE SURGEON COMBINING 'SEASPINE TLIF CAGE DEVICE' WITH MEDTRONIC INFUSE BONE MORPHOGENIC PROTEIN (BMP)." "INJURIES INCLUDE BUT ARE NOT LIMITED TO: TOTAL DISABILITY UNABLE TO WORK IN FORMER PROFESSIONAL CAPACITIES. INTRACTABLE PAIN. INTENTIONAL LACERATION/ INJURY TO DURAL MEMBRANE FOR DEMONSTRATION PURPOSES. CSF LEAKAGE EVENTS SINCE SURGERY. NON FUSION. ECTOPIC BONE GROWTH AT OPERATED SEGMENTS. SCREW PROTRUSION INTO SOFT TISSUE BEYOND VERTEBRAL WALL. ACCELERATED ADJACENT SEGMENT DEGENERATION. POSSIBLE CANCER. BUSINESS/FINANCIAL LOSSES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69457 TLIF CAGE DEVICE CAGE DEVICE MAX SEASPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S MEDTRONIC INFUSE BMP| STRYKER SPINE SCREWS