SPINAL elements

SAVANNAH SPINAL Systems Instructions for Use

7 Pages

Spinal Elements, Inc. · 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 · U.S.A. · 760.607.0121  SAVANNAH SPINAL SYSTEM IMPLANTS AND INSTRUMENTATION  This package insert covers the Savannah® Spinal System and Manual Surgical Instruments that are used for the implantation of this system. Specific sections for implants and instrumentation highlight important user information for only those devices. GENERAL INFORMATION Implants Spinal Elements’ Savannah® Spinal System is comprised of a variety of pedicle screws, mono-axial and poly-axial screw heads, connecting rods, set screws, and transverse crossmembers, called the Savannah-Link. System components are available in a multitude of sizes and configurations. A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient. All implant components are made from titanium alloy (Ti-6Al-4V) conforming to ASTM F 136 or ASTM F1472 and are provided non-sterile for single-use. Spinal Elements’ instruments are manufactured from various stainless steels, titanium, aluminums, and polymers. All materials used have a history of use in such instruments. All implants are intended for single patient use only and should not be reused (used in additional patients) under any circumstances. Reuse may result in serious injury or death. Components from this system should not be used in conjunction with components from other systems. Navigated instruments are manual surgical instruments manufactured from stainless steel, as specified in ASTM F899 or ASTM A564. Navigated instruments are non-sterile and are intended to be used with the Medtronic StealthStation® System. INDICATIONS The Savannah® is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine, specifically as follows: When intended for pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients the Savannah® is indicated for one or more of the following: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and/or failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the Savannah® is indicated for skeletally mature patients having degenerative spondylolisthesis with objective evidence of neurologic impairment and/or severe spondylolisthesis (grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; who are receiving fusions using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and who are having the device removed after the development of a solid fusion mass. Spinal Elements Navigated Instruments are intended to be used during the preparation and placement of Spinal Elements Savannah® screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. CONTRAINDICATIONS 1. Any abnormality present which affects the normal process of bone remodeling including, but not limited to, severe osteoporosis involving the spine, active infection at the site or certain metabolic disorders affecting osteogenesis. 2. Insufficient quality or quantity of bone which would inhibit rigid device fixation. 3. Previous history of infection. 4. Excessive local inflammation. 5. Open wounds. 6. Any neuromuscular deficit which places an unusually heavy load on the device during the healing period. 7. Obesity. An overweight or obese patient can produce loads on the spinal system which can lead to failure of the fixation of the device or to failure of the device itself. 8. Patients having inadequate tissue coverage of the operative site.  LB-005  Page 1 of 7  Rev. 20210519
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