Medtronic 4361130 Instructions for Use

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