Infuse bone3/15/2023 ![]() ![]() Prospective patients should be skeletally mature. Infuse Bone Graft must be applied within 14 days after the initial fracture. Infuse Bone Graft is indicated for treating acute, open tibial shaft fractures that have been stabilized with IM nail fixation after appropriate wound management. An electronic version of the package insert may be found at CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician with appropriate training or experience. The package insert also matches the sizes of those sized devices that are indicated for use with the appropriate Infuse™ Bone Graft kit. Please see the Infuse™ Bone Graft package insert for the complete list of indications, warnings, precautions, adverse events, clinical results, definition of DDD, and other important medical information. Women of child- bearing potential should be advised to not become pregnant for one year following treatment with this device. The safety and effectiveness of this device has not been established in nursing mothers. Women of child bearing potential should be warned by their surgeon of potential risk to a fetus and informed of other possible orthopedic treatments. In an experimental rabbit study, rhBMP-2 has been shown to elicit antibodies that are capable of crossing the placenta. There are no adequate and well-controlled studies in human pregnant women. The Infuse™ Bone Graft/Medtronic Interbody Fusion Device is contraindicated for patients with a known hypersensitivity to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen, or to other components of the formulation and should not be used in the vicinity of a resected or extant tumor, in patients with any active malignancy, or patients undergoing treatment for a malignancy in patients who are skeletally immature in pregnant women or in patients with an active infection at the operative site or with an allergy to titanium, titanium alloy, or polyetheretherketone (PEEK). The LT-Cage™ Lumbar Tapered Fusion Device, the Perimeter™ Interbody Fusion Device, the Clydesdale™ Spinal System, the Divergence-L™ Anterior/Oblique Lumbar Fusion System, and the Pivox™ Oblique Lateral Spinal System implants are not to be used in conjunction with either the Inter Fix™ OR Inter Fix™ RP implants to treat a spinal level. NOTE: The Inter Fix™ Threaded Fusion Device and the Inter Fix™ RP Threaded Fusion Device may be used together to treat a spinal level. 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.The following interbody devices and surgical approaches may be used with Infuse™ Bone Graft: The Infuse™ Bone Graft/Medtronic Interbody Fusion Device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1, who may also have up to Grade I spondylolisthesis or Grade 1 retrolisthesis at the involved level. Infuse™ Bone Graft/Pivox™ Oblique Lateral Spinal System Infuse™ Bone Graft/Divergence-L™ Anterior/Oblique Lumbar Fusion System Infuse™ Bone Graft/Clydesdale™ Spinal System Infuse™ Bone Graft/Perimeter™ Interbody Fusion Device Infuse™ Bone Graft/Inter Fix™ RP Threaded Fusion Device Infuse™ Bone Graft/Inter Fix™ Threaded Fusion Device Infuse™ Bone Graft/LT-Cage™ Lumbar Tapered Fusion Device BRIEF SUMMARY OF INDICATIONS, CONTRAINDICATIONS, AND WARNINGS FOR: ![]()
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