SPINAL elements


5 Pages

Spinal Elements, Inc. · 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 · U.S.A. · 760.607.0121  LOTUS® POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM IMPLANTS AND INSTRUMENTATION This package insert covers the Lotus® Posterior Cervical/Thoracic Spinal System and Manual Surgical Instruments that are used for the implantation of this system. GENERAL INFORMATION The Lotus Posterior Cervical/Thoracic Spinal System consists of a variety of fixation devices manufactured from Ti-6Al-4V that are attached to the spine. Screws may be placed from a posterior approach into the cervical and/or thoracic spine. Hooks may be placed on the posterior elements of the various vertebrae. Rods span the distance between the screws/hooks, and various other connectors may be used between rods or between rods and screws/hooks. The system achieves fixation by the mechanical joining of the rods, screws, hooks and connectors. A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient. All implants are intended for single patient use only and should not be reused (used in additional patients) under any circumstances. INDICATIONS The Spinal Elements Lotus Posterior Cervical/Thoracic Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Lotus Posterior Cervical/Thoracic Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the Lotus Posterior Cervical/Thoracic Spinal System may be connected to the Mercury® or Overwatch® Spinal System with 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 Spinal System. Refer to the Mercury Spinal System package insert for a list of the Mercury Spinal System indications for use. CONTRAINDICATIONS 1. Patients with known or probable intolerance to the materials used in the manufacture of this device. 2. Patients with infection, inflammation, fever, tumors, elevated white blood count, obesity, pregnancy, mental illness and other medical conditions which would prohibit beneficial surgical outcome. 3. Patients resistant to following post-operative restrictions on movement especially in athletic and occupational activities. 4. Use with components from other systems. This system is manufactured from titanium alloy. It should not be used in combination with stainless steel components. 5. Grossly distorted anatomy caused by congenital abnormalities. 6. Any patient that has had prior fusion surgery at the levels to be treated. 7. Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery. 8. Rapid joint disease, bone absorption, osteopenia. Osteoporosis is a relative contraindication since this condition may limit the degree of obtainable correction, stabilization, and/or the amount of mechanical fixation. 9. Any case where the implant components selected for use would be too large or too small to achieve a successful result. 10. Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality. 11. Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance. 12. Any case not described in the indications for use. 13. Reuse or multiple use. WARNINGS Implants and instruments are provided non-sterile and must be cleaned and sterilized before use. Validated sterilization cycle parameter protocols are noted in the STERILIZATION section of this insert. Some instruments may be sharp, depending on their intended use. Care should be taken in handling such instruments to avoid injury to the user or patient. A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where many extenuating circumstances may compromise the results. System components are temporary implants used for the correction and stabilization of the spine. This system is intended to be used to augment the development of a spinal fusion by providing INS-PCT  Page 1 of 5  Rev. 20190919
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File Name: SPINAL elements - INS-PCT - LOTUS POSTERIOR CERVICAL - THORACIC SPINAL System Instructions for Use.pdf

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