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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 ΣΠΟΝΥΛΙΚΟ 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 800 933 2635 (In U.S.A.)
Tel: + 31 45 566 80 00 901 396 3133 (Outside U.S.A.)
Fax 901 396 0356
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.
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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.
6. The type of construct to be assembled for the case should be determined prior to beginning the 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.
7. Unless sterile packaged, all parts should be cleaned and sterilized before use. Additional sterile components should be available in case of an unexpected need.
INTRAOPERATIVE
1. The instructions in any available applicable surgical technique manual should be carefully followed.
2. At all times, extreme caution should be used around the spinal cord and nerve roots. Damage to the nerves will cause loss of neurological functions.
3. Breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel.
4. To assure proper fusion below and around the location of the 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 to the lower vertebrae being
fused.
POSTOPERATIVE
The physician’s postoperative directions and warnings to the patient and the corresponding patient compliance are extremely important.
1. 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 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.
2. 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.
3. 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.
4. 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.
5. Any retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible.
PACKAGING
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.
CLEANING AND DECONTAMINATION
Unless just removed from an unopened MEDTRONIC package, all instruments and implants must be disassembled (if applicable) and cleaned using neutral cleaners before sterilization and introduction into a sterile surgical field or (if
applicable) return of the product to MEDTRONIC. Cleaning and disinfecting of instruments can be performed with aldehyde-free solvents at higher temperatures. Cleaning and decontamination must include the use of neutral cleaners
followed by a deionized water rinse.
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. 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.
STERILIZATION
T2™ Spinal System components may be provided sterile or non-sterile. Unless marked otherwise, implants from other Medtronic spinal systems specifically indicated for use with the T2™ Spinal System, described in this insert are provided
non-sterile and must be sterilized prior to use. 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:
METHOD CYCLE TEMPERATURE EXPOSURE TIME DRY TIME
Steam Pre-Vacuum 270°F (132°C) 4 Minutes 30 Minutes
Steam Gravity 250°F (121°C) 60 Minutes 30 Minutes
Steam* Pre-Vacuum * 273°F (134°C)* 20 Minutes* 30 Minutes*
Steam* Gravity* 273°F (134°C)* 20 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. *For outside the
United States, 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.
PRODUCT COMPLAINTS
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 per form 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.
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, please contact MEDTRONIC.
© 2010 MEDTRONIC SOFAMOR DANEK USA, Inc. All rights reserved.
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