SPINAL elements

OVERWATCH SPINAL System Instructions for Use

7 Pages

Spinal Elements, Inc. · 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 · U.S.A. · 760.607.0121  OVERWATCH SPINAL SYSTEM IMPLANTS AND INSTRUMENTATION  This package insert covers the Overwatch 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’ Overwatch Spinal System is comprised of a variety of screws, hooks, rods, and connectors for fixation of the lumbar and/or sacral spine. 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 F 1472 and Cobalt-Chrome Rods are made from cobalt chromium alloy (CoCr) conforming to ASTM F 1537. Instruments 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. 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 Overwatch Spinal System is intended to provide immobilization and stabilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (Tl -S1). Screws may be placed from the thoracic spine through the sacral spine and into the ilium. This system is intended for anterior/ anterolateral non-pedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion This system is intended to be used with bone graft. The Spinal Elements Overwatch Fixation System may be used in conjunction with the Spinal Elements Mercury® System. In order to achieve additional levels of fixation, the Mercury or Overwatch Fixation Systems may be connected to the Lotus® Posterior Cervical/Thoracic rod connectors. Transition rods with differing diameters may also be used to connect the Lotus Posterior Cervical/Thoracic Spinal System to the Mercury or Overwatch Spinal Systems. Refer to the Lotus Posterior Cervical/Thoracic Spinal System package insert for a list of Lotus indications for use. When used for posterior non-cervical pedicle screw fixation in pediatric patients the Overwatch and Mercury implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Spinal Elements Navigated Instruments are intended to be used during the preparation and placement of Spinal Elements Overwatch 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. LB-179  Page 1 of 7  Rev. 20210712
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File Name: SPINAL elements - LB-179 - OVERWATCH SPINAL System Instructions for Use - 2021-07.pdf

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