Medtronic 9351328 Instructions for Use

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T2TM SPINAL SYSTEM 0381364 Rev. C

IMPORTANT INFORMATION ON THE T2™ SPINAL SYSTEM

INFORMATIONS IMPORTANTES SUR LE SYSTÈME DE FIXATION RACHIDIENNE T2™

INFORMAÇÕES IMPORTANTES SOBRE O SISTEMA DA COLUNA T2™

WICHTIGE INFORMATIONEN ZUM T2™ SPINALSYSTEM

INFORMAZIONI IMPORTANTE SUL SISTEMA SPINALE T2TM

BELANGRIJKE INFORMATIE OVER HET T2™RUGGENGRAATSYSTEEM

VIGTIGE OPLYSNINGER OM T2TM SPINALSYSTEMET

VIKTIG INFORMATION OM T2TM SPINALSYSTEM
VIKTIG INFORMASJON OM T2TM SPINALSYSTEM

TÄRKEÄÄ TIETOA T2™SPINAALIJÄRJESTELMÄSTÄ
ΣΗΜΑΝΤΙΚΕΣ ΠΛΗΡΟΦΟΡΙΕΣ ΓΙΑ ΤΟ ΣΠΟΝΥΛΙΚΟ ΣΥΣΤΗΜΑ T2™
INFORMAÇÕES IMPORTANTES SOBRE O SISTEMA DA COLUNA T2™

DŮLEŽITÉ INFORMACE O SPINÁLNÍM SYSTÉMU T2TM

TÄHTIS TEAVE T2™ SPINAALSÜSTEEMI KOHTA

FONTOS TUDNIVALÓK A T2™ GERINCRENDSZERHEZ

SVARĪGA INFORMĀCIJA PAR T2™ MUGURKAULA FIKSĀCIJAS SISTĒMU

SVARBI INFORMACIJA APIE T2™ STUBURO SISTEMĄ

WAŻNE INFORMACJE O SYSTEMIE KRĘGOSŁUPOWYM T2™

DÔLEŽITÉ INFORMÁCIE O SPINÁLNOM SYSTÉME T2™

02/2010

Medtronic B.V. Medtronic Sofamor Danek USA, Inc.

Earl Bakkenstraat 10 1800 Pyramid Place
6422 PJ Heerlen Memphis, TN 38132
The Netherlands Telephone [phone] (In U.S.A.)
Tel: + 31 45 566 80 00 901 396 3133 (Outside U.S.A.)
Fax [phone]

ENGLISH

The T2™ Spinal 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.

DESCRIPTION

The T2™ Spinal System is a distractible system. This construct 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 construct is not intended
to be used as a stand alone device. The construct is intended to be used with either anterior and/or posterior supplemental spinal fixation systems already cleared for thoracic and lumbar spine stabilization.

The T2 SCEPTOR™ endcleat device is made of titanium alloy. The T2 SCEPTOR™ device must be used in conjunction with PYRAMESH-C® centerpieces. The T2 SCEPTOR™ end caps and end cleats are attached to the PYRAMESH-C® device to
accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.

The T2 XVBR™ expanding cage is made of titanium alloy, cobalt chrome, and nitinol. The T2 XVBR™ end caps are attached to the T2 XVBR™ expanding cage to accommodate the individual anatomical requirements of the vertebral space
created by the corpectomy.

The T2 SCEPTOR™ Spinal System and the T2 XVBR™ Spinal System are 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™ Spinal System constructs may not be used with stainless steel supplemental fixation devices. One of the following Medtronic spinal systems or their successors must be used with the T2™ Spinal System.

Anterior Posterior

ZPLATE-II™ Anterior Fixation System √
DYNA-LOK CLASSIC® Spinal System √ √
VANTAGE® Anterior Fixation System √
TSRH® Spinal System √ √
CD HORIZON® Spinal System √ √

Do not use implant components from any other manufacturer with T2™ Spinal 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.

INDICATIONS

The T2™ Spinal 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™ components consist
of end caps which must be attached to a T2 XVBR™ expanding centerpiece to form a complete construct. The final construct is to be used with supplemental fixation. The T2 SCEPTOR™ components also serve as a vertebral body replacement
device for the same intended use in the thoracolumbar s

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IMPORTANT INFORMATION ON THE T2TM SPINAL SYSTEM

ine. The T2 SCEPTOR™ end caps and endcleats must be attached to a PYRAMESH-C® device to form a complete construct. Both constructs (T2 XVBR™ and T2 SCEPTOR™) must be used

with supplemental fixation to form a final construct. Specifically, the construct is to be used with the Medtronic ZPLATE II™ Anterior Fixation System, the DYNA-LOK CLASSIC® Spinal System, the VANTAGE™ Anterior Fixation System, the TSRH®
Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2™ Spinal System construct is intended to be used with allograft and/or autograft.

CONTRAINDICATIONS

The T2™ Spinal System is not intended for cervical surgical implantation.

Contraindications include, but are not limited to:

1. Infection, local to the operative site.

2. Signs of local inflammation.

3. Fever or leukocytosis.

4. Morbid obesity.

5. Pregnancy.

6. Mental illness.

7. 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.

8. Suspected or documented metal allergy or intolerance.

9. Any case needing to mix metals from different components.

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

11. Any case not described in the indications.

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

13. 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:

1. Severe bone resorption.

2. Osteomalacia

3. 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:

1. Early or late loosening of the components. Implant migration.

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

3. Foreign body (allergic) reaction to the implants, debris, corrosion products, including metallosis, staining, tumor formation and/or autoimmune disease.

4. Infection.

5. Dural tears, pseudomeningocele, fistula, persistent CSF leakage, meningitis.

6. Tissue or nerve damage, irritation, and/or pain caused by improper positioning and placement of implants or instruments.

7. 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.

8. Cauda equina syndrome, neuropathy, neurological deficits (transient or permanent), paraplegia, paraparesis, reflex deficits, arachnoiditis, and/or muscle loss.

9. Scar formation possibly causing neurological compromise around nerves and/or pain.

10. Urinary retention or loss of bladder control or other types of urological system compromise.

11. Bone loss or decrease in bone density, possibly caused by stress shielding.

12. Subsidence of the device into vertebral body(ies).

13. Postoperative change in spinal curvature, loss of correction, height, and/or reduction.

14. Loss of spinal mobility or function. Inability to perform the activities of daily living.

15. Non-union (or pseudarthrosis). Delayed union. Mal-union.

16. 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.

17. Graft donor site complications including pain, fracture, infection, or wound healing problems.

18. Herniated nucleus pulposus, disc disruption or degeneration at, above, or below the level of surgery.

19. Ileus, gastritis, bowel obstruction or other types of gastrointestinal system compromise.

20. Hemorrhage, hematoma, occlusion, seroma, edema, embolism, stroke, excessive bleeding, phlebitis, damage to blood vessels, or cardiovascular system compromise. Wound necrosis or wound dehiscence.

21. Reproductive system compromise, including sterility, loss of consortium, and sexual dysfunction.

22. Development of respiratory problems, e.g. pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.

23. Change in mental status.

24. 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™ Spinal 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.

Never reuse an internal fixation device under any circumstances. Even when a removed device appears undamaged, it may have small defects or internal stress patterns that may lead to early breakage. Damage of the thread will reduce
the stability of the instrumentation.

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.

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:

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

1. Only patients that meet the criteria described in the indications should be selected.

2. Patient conditions and/or predispositions such as those addressed in the aforementioned contraindications should be avoided.

3. Care should be used in the handling and storage of the implant components. The implants should not be scratched or damaged. Implants and instruments should be protected during storage especially from corrosive environments.

4. Further information on the use of this system will be made available on request.

5. 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 that all parts and necessary instruments are present
before the surgery begins.