Category: Thoracolumbar Revision Surgery
Renowned as one of the most innovative spine systems on the market today, the EXPEDIUM® 5.5 System provides technological advancements to treat an unparalleled range of spinal pathologies. The EXPEDIUM System offers a comprehensive solution for rigid posterior fixation of the thoracolumbar regions of the spine.
The EXPEDIUM System is a hook, rod and screw system comprised of a variety of implant options including:
Through unique design innovations, the EXPEDIUM System combines simplicity and versatility allowing the surgeon to design the construct based on intra-operative developments and individual patient anatomy.
The EXPEDIUM System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The EXPEDIUM System is intended for non-cervical pedicle fixation and non-pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumour; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Disease conditions that have been shown to be safely and predictably managed without the use of internal fixation devices are relative contraindications to the use of these devices.
Active systemic infection or infection localised to the site of the proposed implantation are contraindications to implantation.
Severe osteoporosis is a relative contraindication because it may prevent adequate fixation of spinal anchors and thus preclude the use of this or any other spinal instrumentation system.
Any entity or condition that totally precludes the possibility of fusion, i.e., cancer, kidney dialysis, or osteopenia is a relative contraindication. Other relative contraindications include obesity, certain degenerative diseases, and foreign body sensitivity. In addition, the patient’s occupation or activity level or mental capacity may be relative contraindications to this surgery. Specifically, patients who because of their occupation or lifestyle, or because of conditions such as mental illness, alcoholism, or drug abuse, may place undue stresses on the implant during bony healing and may be at higher risk for implant failure. See also the WARNINGS, PRECAUTIONS AND POSSIBLE ADVERSE EFFECTS CONCERNING TEMPORARY METALLIC INTERNAL FIXATION DEVICES section of this insert.
WARNINGS, PRECAUTIONS, AND POSSIBLE ADVERSE EFFECTS CONCERNING TEMPORARY METALLIC INTERNAL FIXATION DEVICES
Following are specific warnings, precautions, and possible adverse effects that should be understood by the surgeon and explained to the patient. These warnings do not include all adverse effects that can occur with surgery in general, but are important considerations particular to metallic internal fixation devices. General surgical risks should be explained to the patient prior to surgery.
|TOP NOTCH® Feature||
|Smart Screw Design||
|Square Thread Closure Mechanism||
|Dual Innie Independent Locking Technology||
|Multiple Options for Sacropelvic Fixation||