EXPEDIUM SPINE SYSTEM PDF

The EXPEDIUM Spine System incorporates technique-simplifying designs, including a state of the art internal closure mechanism and a comprehensive set of. The EXPEDIUM VERSE SPINAL SYSTEM has two configurations. The first configuration utilizes the classic solid shank, double lead threadform found on. The EXPEDIUM Spine System is a innovative spine solution with technological advancements that truly differentiate it from other systems.

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EXPEDIUM Spine System – SPINEMarketGroup

Click here to visit http: Through unique design innovations, the EXPEDIUM Spine System combines simplicity and versatility allowing the surgeon to design the construct based on intra-operative developments and individual patient anatomy. The EXPEDIUM Spine 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.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis.

Pediatric pedicle screw fixation is limited to a posterior approach. 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.

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Active systemic infection or infection localized 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. Other relative contraindications include obesity, certain degenerative diseases, and foreign body sensitivity.

EXPEDIUM® Spine System and EXPEDIUM® Spine System | DePuy Synthes Companies

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. The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation.

These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis grades 3 and 4 of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion pseudarthrosis. The safety and effectiveness of these devices syxtem any other conditions are unknown.

The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient. The surgeon must be thoroughly knowledgeable not only in the medical and surgical aspects of the implant, but epine also be aware of the mechanical and metallurgical limitations spne metallic surgical implants.

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Postoperative care is extremely important.

The patient must be instructed in the limitations of the metallic implant and be warned regarding weight bearing and body stresses on the appliance prior to firm bone healing. The patient should be warned that noncompliance with postoperative instructions could lead to failure of the implant and possible need thereafter for additional surgery to remove the device. This product has labeling limitations.

See package insert for additional warnings, precautions and possible adverse effects. USA law restricts this device to spin by or on the order of physician.

EXPEDIUM Spine System

All medical devices have associated risks. Please refer to the package insert and other labeling for a complete list of indications, contraindications, precautions and warnings.

The content on this page is intended for Healthcare Professionals. If you are a patient, click here.