SPINAL elements

LUCENT 3D Instructions for Use

5 Pages

Spinal Elements, Inc. · 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 · U.S.A. · 760.607.0121  LUMBAR SPINE IMPLANTS AND INSTRUMENTATION (LUCENT® 3D)  This package insert covers the Lucent 3D system and manual surgical instruments that are used for the implantation of this system. LUCENT® 3D GENERAL INFORMATION Spinal Elements’ Lucent® 3D devices are generally box-shaped devices that have various graft windows throughout their geometry. These devices are made from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F3001. 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. INDICATIONS Lucent® 3D devices are intervertebral body fusion devices intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These devices are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). These devices are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) months’ non-operative treatment prior to being treated with these devices. CONTRAINDICATIONS 1. Patients with known or probable intolerance to the material 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. 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 Devices are provided non-sterile and must be sterilized before use. Validated sterilization cycle parameter protocols are noted in the STERILIZATION section of this insert. Implants that have come in direct contact with a patient or bio-contaminants should be disposed of. 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. Devices are intended to be used to augment the development of a spinal fusion by providing temporary INS-L3D  Page 1 of 5  Rev. 20210610
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