Complex interbody device systems
<p>The T2 Altitude™ expandable corpectomy system is an adjustable thoracolumbar replacement for a damaged or unstable vertebral body.</p>
The T2 Altitude™ expandable corpectomy system is intended for vertebral body replacement to aid in the surgical correction and stabilization of the spine for tumor and trauma pathologies. This system is indicated for single and two-level use only in the thoracic and lumbar anterior spine.
The T2 Altitude™ expandable corpectomy system is a distractible system. This device is inserted between two vertebral bodies in the thoracic and lumbar spine and is expanded to aid in the surgical correction and stabilization of the spine. The device may be implanted through a lateral or posterior approach using a minimally invasive technique or implanted through a lateral, posterior or anterior approach through a traditional open technique. The device is not intended to be used as a standalone implant.
One of the following Medtronic spinal systems or their successors must be used with the T2 Altitude™ system.
Do not use implant components from any other manufacturer with T2 Altitude™ expandable corpectomy system components. Stainless steel and titanium implants are not compatible with each other. They must not be used together in a construct. As with all orthopedic implants, in no case may the implants be reused. The T2 Altitude™ expandable corpectomy system is made of titanium alloy, cobalt chrome, and nitinol. The optional T2 ALTITUDE™ angled end caps may be attached to the T2 Altitude™ expanding centerpiece to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.
The T2 Altitude™ expandable corpectomy system is available in multiple diameters and heights to accommodate the patient’s anatomical requirements.
No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MDT Catalog for further information about warranties and limitations of liability.
The T2 Altitude™ expandable corpectomy system is a vertebral body replacement system intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The T2 Altitude™ expandable centerpiece may be used with or without optional modular endcaps, which accommodate individual anatomic requirements. The device is to be used with supplemental fixation. Specifically, the construct is to be used with the Vantage™ anterior fixation system, the TSRH™ spinal system, the CD Horizon™ spinal system, or their successors.
Additionally, the T2 Altitude™ expandable corpectomy system is intended to be used with allograft and/or autograft.
H2 Contraindications
The T2 Altitude™ expandable corpectomy system is not intended for cervical surgical implantation. Contraindications include, but are not limited to:
Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors or congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count.
Nota bene: Although not absolute contraindications, conditions to be considered as potential factors for not using this device include:
All of the possible adverse events or complications associated with spinal fusion surgery without instrumentation are possible. With instrumentation, a listing of possible adverse events or complications includes, but is not limited to:
Note: Additional surgery may be necessary to correct some of these anticipated adverse events.
A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where other patient conditions may compromise the results. This system is not intended to be the sole means of spinal support.
The T2 Altitude™ expandable corpectomy system must be used with additional anterior or posterior instrumentation to augment stability. Use of this product without a bone graft may not be successful. No spinal implant can withstand body loads without the support of bone. In this event, bending, loosening, disassembly, and/or breakage of the device(s) will eventually occur.
Preoperative and operating procedures including knowledge of surgical techniques, proper selection and placement of the implant, and good reduction are important considerations in the success of surgery. Installation and positional adjustment of implants must only be done with special equipment and instruments specific to these devices. They must not be used with other instrumentation unless specifically recommended by Medtronic because the combination with other instrumentation may be incompatible and may not be guaranteed.
This device was designed for single patient use only. Do not reuse or reprocess this product. Reuse or reprocessing may compromise the structural integrity of the device and/or create a risk of contamination of the device which could result in patient injury, illness, or death.
Further, the proper selection and compliance of the patient will greatly affect the results. Patients who smoke have been shown to have an increased incidence of non-unions. These patients should be advised of this fact and warned of this consequence. Obese, malnourished, and/or alcohol abuse patients are also poor candidates for spine fusion.
The T2 Altitude™ expandable corpectomy system , with 25 mm expandable
centerpiece (9392568) with 15 degree endcaps (9402515) was determined to be MR conditional based on product comparison to the T2 XVBR™ spinal system generation 1.0 (9352574) with 8 degree end caps (93272508). A patient with this device can be safely scanned immediately after device placement under the following conditions:
In non-clinical testing, the T2 Altitude™ expandable corpectomy system produced a temperature rise of less than 2.8° C at a maximum whole body averaged specific absorption rate (SAR) of 2.1 W/kg, as assessed by calorimetry for 15 minutes of MR scanning (per pulse sequence) in a 1.5-Tesla (1.5-Tesla/64-MHz, Magnetom, Siemens Medical Solutions, Malvern, PA. Software Numaris/4, Version Syngo MR 2002B DHHS). Additionally, the T2 Altitude™ expandable corpectomy system produced a temperature rise of less than 2.4° C at a maximum whole body averaged specific absorption rate (SAR) of 2.7 W/kg, as assessed by calorimetry for 15 minutes of MR scanning (per pulse sequence) in a 3-Tesla (3-Tesla/128-MHz, Excite, G3.0-052B, General Electric Healthcare, Milwaukee, WI).
MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the T2 Altitude™ expandable corpectomy system . The artifact size information is as follows:
The image artifact extends approximately 20 mm from the device, when scanned in non-clinical testing using the gradient echo pulse sequence in a 3-Tesla MR system (Excite, HDx, Software 14X.M5, General Electric Healthcare, Milwaukee, WI) with a transmit/receive RF body coil.
Physician note: Although the physician is the learned intermediary between the company and the patient, the important medical information given in this document should be conveyed to the patient.
For U.S. audiences only
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
Other preoperative, intraoperative, and postoperative warnings and precautions are as follows.
The selection of the proper size, shape and design of the implant for each patient is crucial to the success of the procedure. Unless great care is taken in patient selection, proper placement of the implant, and postoperative management to minimize stresses on the implant, such stresses may cause metal fatigue and consequent breakage, bending or loosening of the device before the healing process is complete, which may result in further injury or the need to remove the device prematurely.
The physician’s postoperative directions and warnings to the patient and the corresponding patient compliance are extremely important.
Detailed instructions on the use and limitations of the device should be given to the patient. 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 device are complications that can occur as a result of excessive weight bearing or muscular activity. The risk of bending, loosening, or breakage of a temporary 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 weight-supporting devices. The patient should be warned to avoid falls or sudden jolts in spinal position.
To allow the maximum chances for a successful surgical result: the patient or device should not be exposed to mechanical vibrations that may loosen the device construct. The patient should be warned of this possibility and instructed to limit and restrict physical activities, especially lifting and twisting motions and any type of participation in sports. The patient should be advised not to smoke or consume excess alcohol during the bone graft healing process.
The patients should be advised of their inability to bend at the point of spinal fusion and taught to compensate for this permanent physical restriction in body motion.
Failure to immobilize a delayed or non-union of bone will result in excessive and repeated stresses on the implant. By the mechanism of fatigue, these stresses can cause eventual bending, loosening, or breakage of the device. It is important that immobilization of the union is established and confirmed by roentgenographic examination. Where there is a non-union, or if the components loosen, bend, and/or break, the device should be revised and/or removed immediately before serious injury occurs.
Any retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible.
Packages for each of the components should be intact upon receipt. If a loaner or consignment system is used, all sets should be carefully checked for completeness and all components should be carefully checked for lack of damage prior to use. Damaged packages or products should not be used and should be returned to Medtronic. Remove all packaging material prior to sterilization. Only sterile implants and instruments should be used in surgery. Always immediately resterilize all implants and instruments, which have been previously in the operation area. This process must be performed before handling or returning products to Medtronic.
Unless just removed from an unopened sterile MEDTRONIC package, all instruments and implants must be unpackaged, disassembled (if applicable), and cleaned before sterilization, introduction into a sterile surgical field, or if applicable, return of the product to MEDTRONIC. Remove all packaging materials prior to disassembly (if applicable) and cleaning. Cleaning instructions and associated disassembly instructions (if applicable) can be found at http://manuals.medtronic.com.
Note: Certain cleaning solutions such as those containing formalin, glutaraldehyde, bleach and/or other alkaline cleaners may damage some devices, particularly instruments; these solutions should not be used unless instructed by the Instrument Care, Cleaning and Sterilization Quick Reference Guide part number 0381424. Also, many instruments require disassembly before cleaning.
All products should be treated with care. Improper use or handling may lead to damage and/or possible improper functioning of the device.
Unless marked sterile and clearly labeled as such in an unopened sterile package provided by the company, all implants and instruments used in surgery must be sterilized by the hospital prior to use.
Remove all packaging materials prior to sterilization. Only sterile products should be placed in the operative field. Unless specified elsewhere, these products are recommended to be steam sterilized by the hospital using one of the sets of process parameters below:
In the United States and its territories:
Some non-U.S. health care authorities recommend sterilization according to these parameters so as to minimize the potential risk of transmission of Creutzfeldt-Jakob disease, especially of surgical instruments that could come into contact with the central nervous system.
Note: Because of the many variables involved in sterilization, each medical facility should calibrate and verify the sterilization process (e.g. temperatures, times) used for their equipment.
Any health care professional (e.g., customer or user of this system of products) who has any complaints or who has experienced any dissatisfaction in the product quality, identity, durability, reliability, safety, effectiveness, and/or performance, should notify the distributor, Medtronic. Further, if any of the implanted spinal system component(s) ever “malfunctions” (i.e., does not meet any of its performance specifications or otherwise does not perform as intended), or is suspected of doing so, the distributor should be notified immediately. If any Medtronic product ever “malfunctions” and may have caused or contributed to the death or serious injury of a patient, the distributor should be notified immediately by telephone, fax, or written correspondence. When filing a complaint, please provide the component(s) name and number, lot number(s), your name and address, the nature of the complaint, and notification of whether a written report from the distributor is requested.
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