Medtronic 9401304 Instructions for Use

T2 ALTITUDE™ EXPANDABLE 0381480 Rev. A
CORPECTOMY SYSTEM

IMPORTANT INFORMATION ON THE T2 ALTITUDE™ EXPANDABLE CORPECTOMY SYSTEM

INFORMATIONS IMPORTANTES SUR LE SYSTEME CORPORECTOMIQUE T2 ALTITUDE™

INFORMACIÓN IMPORTANTE SOBRE EL SISTEMA DE CORPECTOMÍA EXPANSIBLE T2 ALTITUDE™

WICHTIGE INFORMATIONEN ZUM T2 ALTITUDE™ ERWEITERUNGSFÄHIGEN KORPEKTOMIE-SYSTEM

IMPORTANTI INFORMAZIONI SUL SISTEMA DI CORPECTOMIA ESPANDIBILE T2 ALTITUDE™

BELANGRIJKE INFORMATIE OVER HET T2 ALTITUDE™ EXPANDEERBARE CORPECTOMIESYSTEEM

VIGTIG INFORMATION OM DET EKSPANDERENDE T2 ALTITUDE™ KORPEKTOMISYSTEM

VIKTIG INFORMATION OM T2 ALTITUDE™ EXPANDERBART KORPEKTOMISYSTEM

VIKTIG INFORMASJON OM DET UTVIDBARE T2 ALTITUDE™-KORPEKTOMISYSTEMET

TÄRKEITÄ TIETOJA LAAJENNETTAVASTA T2 ALTITUDE™ -KORPEKTOMIAJÄRJESTELMÄSTÄ

ΣΗΜΑΝΤΙΚΕΣ ΠΛΗΡΟΦΟΡΙΕΣ ΓΙΑ ΤΟ ΕΠΕΚΤΑΣΙΜΟ ΣΥΣΤΗΜΑ ΣΩΜΑΤΕΚΤΟΜΗΣ T2 ALTITUDE™

INFORMAÇÃO IMPORTANTE SOBRE O SISTEMA DE CORPECTOMIA EXPANSÍVEL T2 ALTITUDE™

DŮLEŽITÉ INFORMACE O KORPEKTOMICKÉM ROZŠIŘITELNÉM SYSTÉMU T2 ALTITUDE™

TÄHTIS TEAVE LAIENDATAVA LÜLIKEHA OSALISE EEMALDAMISE SÜSTEEMI T2 ALTITUDE™ KOHTA

FONTOS INFORMÁCIÓK A T2 ALTITUDE™ TÁGÍTHATÓ CORPECTOMIÁS RENDSZERRŐL

SVARĪGA INFORMĀCIJA PAR T2 ALTITUDE™ PAPLAŠINĀMO KORPEKTOMIJAS SISTĒMU

SVARBI T2 ALTITUDE™ IŠSIPLEČIANČIOS KORPEKTOMIJOS SISTEMOS INFORMACIJA

WAŻNE INFORMACJE DOTYCZĄCE SYSTEMU ROZPRĘŻNEGO DO KORPEKTOMII T2 ALTITUDE™

DÔLEŽITÉ INFORMÁCIE O ROZŠÍRITEĽNOM KORPEKTOMICKOM SYSTÉME T2 ALTITUDE™ ®

0123

2010-11

North Ryde, NSW 2113 Memphis, TN 38132 6422 PJ Heerlen
Australia Telephone [phone] (In U.S.A.) The Netherlands
901 396 3133 (Outside U.S.A.) Tel: + 31 45 566 80 00
Fax [phone]

ENGLISH

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.

IMPORTANT INFORMATION ON THE T2 ALTITUDE™ EXPANDABLE CORPECTOMY SYSTEM

AUSTRALIAN SPONSOR:

Medtronic Australasia Pty Ltd Medtronic Sofamor Danek USA, Inc. Medtronic B.V.

97 Waterloo Rd 1800 Pyramid Place Earl Bakkenstraat 10

DESCRIPTION

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 stand alone implant.

One of the following Medtronic spinal systems or their successors must be used with the T2 ALTITUDE ™ System.

Anterior Posterior

VANTAGE® Anterior Fixation System X
TSRH® Spinal System X X
CD HORIZON® Spinal System X X

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 re-used.

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.

INDICATIONS

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.

CONTRAINDICATIONS

The T2 ALTITUDE™ Expandable Corpectomy System is not intended for cervical surgical implantation. Contraindications include, but are not limited to:

• Infection, local to the operative site.

• Signs of local inflammation.

• Fever or leukocytosis.

• Morbid obesity.

• Pregnancy.

• Mental illness.

• 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.

• Suspected or documented metal allergy or intolerance.

• Any case needing to mix metals from different components.

• Any patient having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition.

• Any case not described in the indications.

• Any patient unwilling to co-operate with postoperative instructions.

• 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 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:

• Early or late loosening of the components and implant migration.

• Disassembly, bending, and/or breakage of any or all of the components.

• Foreign body (allergic) reaction to the 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 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.

MR CONDITIONAL

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 XVBRTM
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:

• Static magnetic field of 1.5 Tesla and 3.0 Tesla only

• Spatial gradient field of 720 Gauss/cm or less

• Maximum whole body average specific absorption rate (SAR) of 2.0 W/kg or less under normal operating mode only, for 15 minutes of scanning.

• No local RF transmit coils shall be placed over the device

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).

Artifact Information

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:
Pulse sequence T1-SE T1-SE GRE GRE

Signal Void Size 5,073mm
Imaging Plane Parallel Perpendicular Parallel Perpendicular

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.

!USA

For US 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:

2

1,879mm2 8,916mm2 4,928mm

2

IMPLANT SELECTION

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.

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 aforementioned contraindications should be avoided.