T2 Stratosphere™ Expandable
M708348B762E Rev. C
Corpectomy System-Thoracolumbar
2019-05-20
IMPORTANT INFORMATION ON THE T2 STRATOSPHERE™ EXPANDABLE
CORPECTOMY SYSTEM-THORACOLUMBAR
PURPOSE
The T2 Stratosphere™ Expandable Corpectomy System-Thoracolumbar 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 twolevel use in the thoracic and lumbar anterior spine.
DESCRIPTION
The T2 Stratosphere™ Expandable Corpectomy System-Thoracolumbar is an adjustable vertebral body replacement device
and features a self-adjusting end cap which provides continuous angulation between 0-8° in any direction to accommodate the
patient’s anatomical requirements.
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, oblique, or posterior approach using a
minimally invasive technique or implanted through a lateral, oblique, posterior, or anterior approach through a traditional open
technique.
The T2 Stratosphere™ Expandable Corpectomy System-Thoracolumbar is intended to be used with supplemental fixation
cleared for use in the thoracolumbar spine. The device is not intended to be used as a stand-alone implant.
The T2 Stratosphere™ Expandable Corpectomy System-Thoracolumbar is made of titanium alloy and is provided sterile and
non-sterile. The centerpieces are available in multiple diameters and heights. The system also features modular end caps which
are available in various angles and geometries.
Do not use implant components from any other manufacturer with T2 Stratosphere™ Expandable Corpectomy SystemThoracolumbar components. Never use titanium or titanium alloy implants with stainless steel in the same construct.
No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use
are specifically excluded.
INDICATIONS
The T2 Stratosphere™ Expandable Corpectomy System-Thoracolumbar is a vertebral body replacement device intended for
use in the thoracic and lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or
trauma (i.e. fracture). The T2 Stratosphere™ Expandable centerpiece may be used with or without optional modular end caps
which accommodate individual anatomic requirements. The device is to be used with supplemental fixation cleared for use in
the thoracic and lumbar spine.
The T2 Stratosphere™ Expandable Corpectomy System-Thoracolumbar is intended for use with autograft or allograft, as an
adjunct to fusion. The T2 Stratosphere™ Expandable Corpectomy System-Thoracolumbar 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft
used at the surgeon’s discretion.
CONTRAINDICATIONS
The T2 Stratosphere™ Expandable Corpectomy System-Thoracolumbar is not intended for cervical surgical implantation.
Contraindications include:
▪ Any case needing to mix metals from different components.
▪ Any case not described in the indications.
▪ Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the presence
of 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.
▪ 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 postoperative instructions.
▪ Any case not needing a bone graft and fusion or where fracture healing is not required.
▪ Any time implant use would interfere with anatomical structures or expected physiological performance.
▪ Signs of local inflammation.
▪ Fever or leukocytosis.
▪ Infection local to the operative site and/or signs of local inflammation.
▪ Mental illness.
▪ Morbid obesity.
▪ Pregnancy.
▪ Suspected or documented metal allergy or intolerance.
▪ These devices must not be used for pediatric cases, nor where the patient still has general skeletal growth.
Contraindications of this device are consistent with those of other spinal systems.
Nota bene: although not absolute contraindications, conditions to be considered as potential factors for not using this device
include:
▪ Severe bone resorption.
▪ Osteomalacia.
▪ Severe osteoporosis.
POSSIBLE ADVERSE EVENTS
All adverse events or complications associated with spinal fusion surgery without instrumentation are possible. With
instrumentation, a listing of possible adverse events or complications includes:
▪ Early or late loosening of components and implant migration.
▪ Disassembly, bending, and/or breakage of any or all components.
▪ Foreign body (allergic) reaction to implants, debris, corrosion products, including metallosis, staining, tumor formation
and/or autoimmune disease.
▪ Infection.
▪ Dural tears, pseudomeningocele, fistula, persistent CSF leakage, and meningitis.
▪ Tissue or nerve damage, irritation, and/or pain caused by improper positioning and placement of implants or instruments.
▪ Loss of neurological function, including paralysis (complete or incomplete), dysesthesia, hyperesthesia, anesthesia,
paraesthesia, appearance of radiculopathy, and/or the development or continuation of pain, numbness, neuroma, tingling
sensation, sensory loss, and/or spasms.
▪ Cauda equina syndrome, neuropathy, neurological deficits (transient or permanent), paraplegia, paraparesis, reflex deficits,
arachnoiditis, and/or muscle loss.
▪ Scar formation possibly causing neurological compromise around nerves and/or pain.
▪ Urinary retention or loss of bladder control or other types of urological system compromise.
▪ Bone loss or decrease in bone density possibly caused by stress shielding.
▪ Subsidence of the device into vertebral body(ies).
▪ Postoperative change in spinal curvature, loss of correction, height, and/or reduction.
▪ Loss of spinal mobility or function.
▪ Inability to perform the activities of daily living.
▪ Non-union (or pseudarthrosis), delayed union, and mal-union.
▪ Fracture, microfracture, resorption, damage, penetration, and/or retropulsion of any spinal bone, of the bone graft, or at the
bone graft harvest site at, above, and/or below the level of surgery.
▪ Graft donor site complications including pain, fracture, infection, or wound healing problems.
▪ Herniated nucleus pulposus, disc disruption or degeneration at, above, or below the level of surgery.
▪ Ileus, gastritis, bowel obstruction, or other types of gastrointestinal system compromise.
▪ Hemorrhage, hematoma, occlusion, seroma, edema, embolism, stroke, excessive bleeding, phlebitis, damage to blood
vessels, cardiovascular system compromise, and wound necrosis or wound dehiscence.
▪ Reproductive system compromise including sterility, loss of consortium, and sexual dysfunction.
▪ Development of respiratory problems (e.g. pulmonary embolism, atelectasis, bronchitis, pneumonia, etc).
▪ Change in mental status.
▪ Death.
Note: additional surgery may be necessary to correct some of these anticipated adverse events
WARNINGS AND PRECAUTIONS
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 results. This system is not intended to be the sole means of spinal support. The T2
Stratosphere™ Expandable Corpectomy System-Thoracolumbar 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) could 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.
A device that has been implanted should never be reprocessed or reused under any circumstances. Sterile packaged devices
should also never be resterilized. Reprocessing or reuse may compromise the structural integrity of these implants and create a
risk of contamination of the implants which could result in patient injury, illness, or death.
Further, proper selection and compliance of the patient will greatly affect the results. Patients who smoke were 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.
MRI INFORMATION
MR Conditional
The T2 Stratosphere™ Expandable Corpectomy System-Thoracolumbar was determined to be MR Conditional based on nonclinical testing and engineering rationales. A patient with this device can be safely scanned immediately after device placement
under the following conditions:
▪ Static magnetic field of 1.5 Tesla and 3 Tesla.
▪ Maximum spatial gradient magnetic field of 3000 Gauss/cm or less.
▪ Maximum whole body average specific absorption rate (SAR) of 2.0 W/kg or less under normal operating mode for 15
minutes of scanning per pulse sequence.
▪ No local RF transmit coils shall be placed over the device.
Under the scan conditions defined, a worst-case corpectomy system representative of the T2 Stratosphere™ Expandable
Corpectomy System-Thoracolumbar produced a maximum temperature rise of less than 7.74°C after 15 minutes of continuous
scanning.
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
Stratosphere™ Expandable Corpectomy System-Thoracolumbar. The image artifact extends approximately 20mm from the
device when imaged with a gradient echo pulse sequence in a 3.0 T MRI system.
The presence of other implants or the health state of the patient may require a modification of MR conditions.
If the T2 Stratosphere™ Expandable Corpectomy System-Thoracolumbar is used in combination with any device which is not
MR Conditional, be advised this combination has not been tested in the MR environment and, therefore, higher heating and
possible injury to the patient may occur.
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 US audiences only
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
IMPLANT SELECTION
Selection of 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.
PREOPERATIVE
▪ Only patients that meet the criteria described in the indications should be selected.
▪ Patient conditions and/or predispositions such as those addressed in the contraindications should be avoided.
▪ Care should be used in the handling and storage of implant components. Implants should not be scratched or damaged.
Implants and instruments should be protected during storage especially from corrosive environments.
▪ Since mechanical parts are involved, the surgeon should be familiar with the various components before using the
equipment and should personally assemble the devices to verify all parts and necessary instruments are present before
surgery.
▪ The type of construct to be assembled for the case should be determined prior to surgery. An adequate inventory of implant
sizes should be available at the time of surgery, including sizes larger and smaller than those expected to be used.
▪ Unless sterile packaged, all devices should be sterilized before use. Additional sterile components should be available in
case of an unexpected need.
INTRAOPERATIVE
▪ Instructions in any available applicable surgical technique manual should be carefully followed.
▪ At all times, extreme caution should be used around the spinal cord and nerve roots. Damage to nerves will cause loss of
neurological functions.
▪ Breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel.
▪ To ensure proper fusion below and around the location of instrumentation, a bone graft should be used. Bone graft must be
placed in the area to be fused and graft material must extend from the upper vertebra to the lower vertebra being fused.
POSTOPERATIVE
The physician’s postoperative directions and warnings to the patient and the corresponding patient compliance are extremely
important.
▪ Detailed instructions on 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 which 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 sport participation. The patient should be
advised not to smoke or consume excess alcohol during the bone graft healing process.
▪ 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
components loosen, bend, and/or break, the device should be revised and/or removed immediately before serious injury
occurs.
▪ Retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible.
PACKAGING
Devices may be supplied in a sterile or non-sterile form. Packages for components should be intact upon receipt. Once the seal
on the sterile package has been broken, the product should not be re-sterilized. Damaged packages or products should not be
used and should be returned to Medtronic.
STERILIZATION
Unless marked sterile and clearly labeled as such in an unopened sterile package provided by the company, all implants 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 the process parameters in Table 1 or Table 2.
Table 1: Sterilization cycle parameters for the US and its territories
Method Cycle Temperature Exposure time
Steam Dynamic-air-removal 270°F (132°C) 4 Minutes 30 Minutes
Steam Dynamic-air-removal 275°F (135°C) 3 Minutes 30 Minutes
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. It is the end user’s responsibility to use only sterilizers and
accessories (such as sterilization wraps, sterilization pouches, chemical indicators, biological indicators, and sterilization
cassettes) cleared by the Food and Drug Administration (FDA) for the selected sterilization cycle specifications (time and
temperature). The sterilization cycles listed in Table 2 are not considered by the FDA to be standard sterilization cycles.
*For medical facilities located outside the US and its territories, some non-US health care authorities recommend sterilization
according to these parameters to minimize the risk of transmission of Creutzfeldt-Jakob disease, especially of surgical
instruments that could come into contact with the central nervous system.
Table 2: Sterilization cycle parameters for medical facilities outside the US and Its territories
Method Cycle Temperature Exposure time
Steam Dynamic-air-removal 273°F (134°C) 4 Minutes 30 Minutes
Steam Dynamic-air-removal 273°F (134°C) 20 Minutes* 30 Minutes
1
The minimum dry times were validated using sterilizers having vacuum drying capabilities. Drying cycles using ambient
atmospheric pressure may require longer dry times. Refer to the sterilizer manufacturer's recommendations.
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.
Minimum dry time
Minimum dry time
1
1
PRODUCT COMPLAINTS
To report product problems, contact Medtronic.
FURTHER INFORMATION
Recommended directions for use of this system (surgical operative techniques) are available at no charge upon request. If
further information is needed or required, contact Medtronic.
©2019 Medtronic Sofamor Danek USA, Inc. All rights reserved.
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
Telephone: 800 933 2635 (USA)
901 396 3133 (Outside USA)
Fax: 901 396 0356
EXPLANATION OF SYMBOLS
Authorized representative in the European Community
CAUTION: Federal law (USA) restricts these devices to
sale by or on the order of a physician.
Do not re-use
Batch code
Manufacturer
Non-sterile
Sterilized using irradiation
Catalogue number
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel: + 31 45 566 80 00
Use-by date
The device complies with European Directive MDD
93/42/EEC
For US audiences only
MR Conditional
Consult instructions for use at this website.
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