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September 3, 2020

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Safety and effectiveness  has not been established  in patients  with  the following conditions:  morbid obesity;  symptomatic cardiac  disease;  pregnancy; signs of local inflammation;  fever or leukocytosis; metal sensitivity/allergy to the implant materials; any medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the elevation  of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count; grossly distorted anatomy due to congenital  abnormalities; osteopenia, and/or osteoporosis (osteoporosis is a relative contraindication since this condition may limit the obtainable correction, the amount of mechanical fixation, and/or the  quality of the bone graft); long term systemic corticosteroid use; active drug abuse; any case requiring the mixing of metals from different components; any patient having inadequate tissue coverage  over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition; any patient unwilling to cooperate with the postoperative instructions; any time implant  utilization would interfere with  anatomical structures or expected physiological performance. The Endoskeleton TCS Interbody Fusion device should not be implanted in patients with an allergy to titanium or titanium alloys. The new bone formation through the implant is intended to provide long-term structural support and fusion at the implanted disc space. Therapies & Procedures Therapies & Procedures The Endoskeleton TL Interbody Fusion Device should not be implanted in patients with a prior fusion at the level(s) to be treated. On  all threaded connections, finger tighten only. Titan Original Surface wins the IMAST Whitecloud Award for Best Basic Science. Spinal & Orthopaedic When threading components together, keep to  the thread axis. An implant holding feature has been incorporated into the trailing surface of the implant to mate with the implant inserter, and to facilitate placement of the implant into the interbody space. Failure to immobilize a delayed or nonunion of bone will result in excessive and repeated stresses  on the implant(s). Proper implant selection and patient compliance to postoperative precautions will greatly affect surgical outcomes. Any retrieved implants should be treated in such a manner that reuse in another surgical procedure is not possible. If partial weight bearing is recommended or required prior to firm bony union, the patient must be warned that bending, loosening or breakage of the implant(s)  are complications which can occur as a result of excessive or  early weight bearing or excessive muscular activity. The surgeon must ensure that all necessary implants and instruments are on hand prior to surgery. The Titan Spine ENDOSKELETON™ TAS or ENDOSKELETON™ TAS Hyperlordotic Interbody Fusion Systems have not been evaluated for safety and compatibility in the MR environment. The Endoskeleton TL Interbody Fusion Device should not be used with components of any other interbody systems. To allow maximum chances for a successful surgical result, the patient should not be exposed to mechanical vibrations that may loosen the implant(s). Device Record History. Inspect internal and external threads for damage prior to assembly. With an updated browser, you will have a better Medtronic website experience. Reuse may result in, but is not limited to the following; infection or bending, loosening or breakage due to impairment of implant integrity. The implants are composed of ASTM F136 Ti 6Al-4V ELI titanium alloy and provided either sterile or non-sterile.An implant holding feature has been incorporated into the trailing surface of the implant to mate with the implant holder, and to facilitate placement of the implant into the interbody space. The patient should be warned to avoid falls or sudden jolts in spinal position. Detailed instructions on the use and limitations of the implant(s) should be given to the patient. Reuse may result in but is not limited to the following; infection or  bending, loosening or breakage due to impairment of  implant integrity. If partial weight bearing is recommended or required prior to firm bony union, the patient must be warned that bending, loosening or breakage of the implant(s) are complications which can occur as a result of excessive or early weight bearing or excessive muscular activity. Brand Name: ENDOSKELETON® TT Version or Model: 4900-1020 Commercial Distribution Status: In Commercial Distribution Catalog Number: 4900-1020 Company Name: TITAN SPINE, LLC Primary DI Number: 00191375003274 Issuing … Screw in the component as far as it will go and make sure that the product is flush with the insertion instrument. If partial weight bearing is recommended or required prior to firm bony union, the patient must be warned that bending, loosening, or breakage of the implant are complications which can occur as a result of excessive or early weight bearing or excessive muscular activity. The risk of bending,  loosening or breakage of an internal fixation device during postoperative rehabilitation may be increased if the patient is active or if the patient is debilitated, demented or otherwise unable to use  crutches or other such weight supporting devices. Robert Henderson, orthopaedic surgeon at Dallas Spine Care in Dallas, Texas, USA, performed one of the first implantations of the Endoskeleton TAS, he commented, “I felt the procedure went very well and the surgical technique was simple and straightforward.”. 2016 May; 4(41) doi: 10.3389/fbioe.2016.00041. Update my browser now. Any instruction manuals should be carefully followed. The implants should not be scratched or otherwise damaged. Patient conditions and/or predispositions such as these should be avoided. Safety and effectiveness has not been established in patients with the following conditions: morbid obesity; symptomatic cardiac disease; pregnancy; signs of local inflammation; fever or leukocytosis; metal sensitivity/allergy to the implants materials; any medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count; grossly distorted anatomy due to congenital abnormalities; osteopenia, and/or osteoporosis (osteoporosis is a relative contraindication since this condition may limit the obtainable correction, the amount of mechanical fixation, and /or the quality of the bone graft); long term systemic corticosteroid use; active drug abuse; any case requiring the mixing of metals from different components; any patient having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition; any patient unwilling to cooperate with the postoperative instructions; any time implant utilization would interfere with anatomical structures or expected physiological performance. 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