The package labeling for the INTER FIX™ RP Threaded Fusionĭevice contains complete product information for this component. However, these two components must be used together. The INTER FIX™ RP Threaded Fusion Device component is sold separately from the INFUSE™ Bone Graft component #INFUSE BONE ISO#Such standards as ASTM F136 or its ISO equivalent. The INTER FIX™ RP Threaded Fusion Device implants are made from implant-grade titanium alloy (Ti-6Al-4V) described by Both ends of the INTER FIX™ RP implant are closed. The INTER FIX™ RP Device consists of a hollow, perforated cylinder with a single, large, outer-radiused groove along theĮntire longitudinal axis that extends into the inside diameter of the device. The package labeling for the INTER FIX™ Threaded Fusion Device containsĬomplete product information for this component. These two components must be used together. The INTER FIX™ Threaded Fusion Device component is sold separately from the INFUSE™ Bone Graft component however, Standards as ASTM F136 or its ISO equivalent. The INTER FIX™ Threaded Fusion Device implants are made from implant-grade titanium alloy (Ti-6Al-4V) described by such The endcaps of the INTERįIX™ cages are sized according to the diameter of the cylinders and are applied to the open end of the cylinders after they are The INTER FIX™ Device consists of a hollow, perforated cylinder with parallel sides and an endcap. Medtronic Titanium Threaded Interbody Fusion Device Components The Infuse™ Bone Graft component must not be used without the Medtronic Interbody Fusion Device component. The bone morphogenetic protein solution component must not be used without the carrier/scaffold component or with a carrier/scaffold component different from the one described in this document. These components must be used as a system for the prescribed indication described above. The Infuse™ Bone Graft / Medtronic Interbody Fusion Device consists of two components containing three parts – a spinal fusion cage, a recombinant human bone morphogenetic protein, and a carrier/scaffold for the bone morphogenetic protein and resulting bone. The Pivox™ Oblique Lateral Spinal System implanted via an OLIF approach at a single-level from L2-L5.The Divergence-L™ Anterior/Oblique Lumbar Fusion System interbody device implanted via an ALIF approach at a single level from L2-S1 or an OLIF approach at a single level from L5-S1.The Clydesdale™ Spinal System, implanted via an OLIF approach at a single level from L2-L5.The Perimeter™ Interbody Fusion Device implanted via a retroperitoneal anterior lumbar interbody fusion (ALIF) at a single level from L2-S1 or an oblique lateral interbody fusion (OLIF) approach at a single level from L5-S1.The Inter Fix™ or Inter Fix™ RP Threaded Fusion Device, implanted via an anterior open approach at a single level.The LT-Cage™ Lumbar Tapered Fusion Device, implanted via an anterior open or an anterior laparoscopic approach at a single level. #INFUSE BONE FREE#Please contact one of our experienced Infuse Bone Graft attorneys via our online form or call 88 for a free and confidential consultation.The following interbody devices and surgical approaches may be used with Infuse™ Bone Graft: If you or someone you know has suffered serious side effects or injuries following use of Infuse Bone Graft in the neck or cervical spine, you may be entitled to legal compensation. Medtronic is now under investigation by the FDA for its illegal promotion of Infuse as safe and effective when used in the neck and cervical spine. When Infuse is used in the neck or cervical spine, it tends to promote unintended bone growth that leads to significant problems such as swelling of the neck, tightening of the airways, and difficulty swallowing, breathing, and speaking.ĭespite knowledge of the risks associated with off-label uses of Infuse, Medtronic paid doctors to cover up and discredit unfavorable study results. Infuse is FDA-approved for use only in the lumbar spine and has been proven to be extremely dangerous when it is used in other parts of the body, specifically the neck and cervical spine. Infuse Bone Graft is a liquid form of recombinant bone morphogenic protein that is housed in a small cage-like structure that is implanted in the spine where it facilitates bone growth to fill gaps between vertebrae and replace damaged disks. Infuse is not FDA-approved for use in the neck and cervical spine, but Medtronic illegally spent millions of dollars to encourage these dangerous off-label uses and to cover up study results showing the severe injuries caused by Infuse. A recent FDA investigation of Medtronic’s Infuse Bone Graft discovered that the product may cause cancer infection, ectopic bone growth, cyst formation, difficulty breathing, nerve damage, and death when the product is used in the neck and cervical spine.
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