Becker's Spine Review

beckers-March-2023-spine-review

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Infinity ™ OCT system and UNiD ™ patient-specific rods Plan • Plan provides preoperative patient-specific measurements and simulates multiple surgical strategies based on surgeon input and key cervical parameters Execute • Execute the surgical plan using the precision and visibility of navigated guidance and patient-specific rods to achieve alignment goals Analyze • Analyze postoperative alignment through advanced analytics and follow patient outcomes over time, including patient-reported outcomes © 2023 Medtronic. UC202311353EN The Infinity ™ OCT 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 craniocervical junction, 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 spine. 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 Infinity ™ OCT system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The Infinity ™ OCT system may be used with PASS ™ OCT patient- specific UNiD ™ OCT rods. In order to achieve additional levels of fixation, the Infinity ™ OCT system may be connected to the CD Horizon ™ spinal system and Vertex ™ reconstruction system rods with the Infinity ™ OCT system rod connectors. Transition rods with differing diameters may also be used to connect the Infinity ™ OCT System to the CD Horizon ™ spinal system. Refer to the CD Horizon ™ spinal system package insert, Vertex ™ reconstruction system and PASS ™ OCT spinal system package insert for a list of the indications of use. Note: The 3.0mm multi axial screw (MAS) requires the use of MAS Crosslink ™ at each level in which the 3.0mm screw is intended to be used. The lateral offset connectors and MAS extension connectors are intended to be used with 3.5mm and larger diameter multi axial screws. The lateral offset connectors and MAS extension connectors are not intended to be used with 3.0mm screws. Note: Segmental fixation is recommended for these constructs. POTENTIAL ADVERSE EVENTS All of the adverse events associated with spinal fusion surgery without instrumentation are possible. With instrumentation, a listing of potential adverse events includes: • Early or late loosening of any or all of the components. • Disassembly, bending, and/or breakage of any or all of the components. • Tissue or nerve damage caused by improper positioning and placement of implants. • Post-operative change in spinal curvature, loss of correction, height, and/or reduction. The UNiD ™ spine analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons and service providers to perform generic, as well as spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software. UNiD™ ASI transition rods are available in 3.5mm to 4.75, 5.5, and 6.0mm • Transition area is exactly where it's needed based on the surgical plan • Transition from Infinity ™ OCT system to CD Horizon ™ Solera ™ and CD Horizon ™ Solera ™ Voyager ™ systems • Rods are industrially produced to be patient-specific, smoothly contoured, aligned with the case plan, and notch-free Contact your Medtronic sales rep or use the QR code to learn more.

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