Translace™ Spinal Tethering System M708348B587E Rev. B
2020-03-10
IMPORTANT INFORMATION ON THE TRANSLACE™ SPINAL TETHERING SYSTEM
PURPOSE
The Translace™ Spinal Tethering System is intended to be used in conjunction with pedicle screw and rod based posterior
fixation systems that help provide immobilization and stabilization of spinal segments.
DESCRIPTION
The Translace™ Spinal Tethering System consists of a connector, a tether, and system specific instrumentation that allows the
spine to be secured to a rod construct at levels where the use of a bone screw is not optimal. The Translace™ Spinal Tethering
System acts as an alternative to sublaminar wires and hooks. The Translace™ Spinal Tethering System is intended to provide
temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.
The Translace™ Spinal Tethering System will supplement the interface between spinal anatomy and rod, through a pedicle
sparing technique. The tether was designed to be used in conjunction with the connector. This system should be implanted only
by a physician thoroughly knowledgeable in the implant's material and surgical aspects and instructed as to its mechanical and
material applications and limitations.
INDICATIONS
The Translace™ Spinal Tethering System is a temporary implant for use in orthopedic surgery. The system is intended to
provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone
fractures. Indications for use include the following applications:
1. Spinal trauma surgery, used in sublaminar or facet wiring techniques.
2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as
idiopathic, congenital and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and
spondylolisthesis.
3. Spinal degenerative surgery, as an adjunct to spinal fusions.
The Translace™ Spinal Tethering System may also be used in conjunction with other medical implants made of similar metals
whenever "wiring" may help secure the attachment of other implants.
CONTRAINDICATIONS
▪ Bone metabolism disorders that potentially compromise the mechanical support expected for this type of implant (any
abnormality affecting the normal functioning of bone tissue including acute spinal osteoporosis, bone resorption,
osteopenia, primary or metastatic tumors of the spine, active infection at the site, and some metabolic disorders that affect
osteogenesis).
▪ Insufficient quality and quantity of bone which would limit the efficacy of osteosynthesis.
▪ Severe fractures such that segments may not be maintained in satisfactory proximate reduction.
▪ Fractures that potentially compromise the mechanical support expected for this type of implant.
▪ Active local or systemic infections, or recent history of local or systemic infections that may jeopardize the outcome of the
operation.
▪ Major local inflammation.
▪ Open wounds.
▪ Immunosuppressive diseases.
▪ Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the
presence of a tumor, 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.
▪ Pregnancy.
▪ Sensitivity to implant materials or foreign bodies. If there is any suspected sensitivity to the materials used, the patient
should have the appropriate tests before selection and implantation of the material.
▪ In any situation where implant use would interfere with anatomical structures or expected physiological performance, such
as impinging on vital structures.
▪ Any other relative contraindication including:
▪ Obesity. A person who is overweight or obese can overload the system leading to failure of fixation or breakage of the
material.
▪ Excessive physical activity. Intense occupational level or activity level of the patient or a state of senility, mental illness,
or other use of psychoactive substances. These conditions, along with others, may lead the patient to neglect surgeon
recommendations, in turn leading to failure of the fixation or rupture of the material.
▪ Any neuromuscular deficit resulting in an unusual overload of the system during the consolidation period.
▪ Patients with insufficient muscle or tissue coverage of the operative site.
▪ Disease conditions shown to be safely and predictably managed without the use of fixation devices.
PRECAUTIONS
▪ The implantation of this type of implant should be performed only by experienced spinal surgeons with specific training in
the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the
patient.
▪ The information in these instructions is necessary but not sufficient for using this system. This information in no way takes
the place of the professional judgment, expertise, and experience of the surgeon in patient selection, preoperative planning
and the choice of implant size, knowledge of the anatomy and biomechanics of the spine, knowledge of the materials and
understanding of the mechanical characteristics of the implants used, training and expertise in spinal orthopedic surgery,
the use of accessory instruments for implantation, and patient commitment to follow an appropriate postoperative plan and
having the expected postoperative exams.
▪ A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where many
extenuating circumstances may compromise results.
▪ The device system is not intended to be the sole means of spinal support. Use of this product without a bone graft or in
cases that develop into a non-union will 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.
▪ Before using the implant, it is absolutely essential to check the integrity of the packaging and to check the expiration date on
the label, which guarantees that sterility has been maintained.
▪ Only physicians who are familiar with and trained on the techniques for using Tether Connector instruments are authorized
to use them.
▪ Instruments must be checked before the procedure to be sure they are not worn or damaged.
▪ Before use, it is advisable to verify the instruments are intact and functioning completely properly.
▪ Surgeons should ensure they are not using instruments that could cause inappropriate tension on the spinal column or on
the implants and must scrupulously follow the operative protocol described in the surgical technique brochure available from
Medtronic. This means, for example, that surgeons must avoid injuring the patient from pressure exerted during in-situ
repositioning of the instrument.
▪ To reduce the risk of breaking, implants should not be bent, folded, struck, or scratched with instruments unless the
Translace™ Spinal Tethering System surgical technique specifies otherwise.
▪ Instruments should be used with extreme caution near vital organs, nerves, and blood vessels.
▪ Instruments can be reused after being reprocessed unless specified.
▪ When hypersensitivity is known or suspected, it is recommended to check the skin tolerance of the implant’s materials
before implantation.
WARNINGS
▪ Depending on the resistance of the patient’s bone, do not apply an excessive force on the braid that could lead to fracture
of the lamina and/or transverse process.
▪ Do not use if package is opened or damaged or if expiration date has passed.
▪ Do not use damaged implants.
▪ Never reuse an implant. Even if it seems to be intact, a previously used implant can have imperfections or defects that
could reduce its lifetime.
▪ Resterilization of this implant is strictly prohibited. If a single-use product is reused, the performance, cleaning and sterility
of the device are no longer assured. This can in particular result in failure of the procedure or risks of infection that can lead
to death of the patient.
▪ It is essential to adhere to aseptic conditions when opening the protective packaging and extracting the implant.
▪ It is extremely important to handle implants carefully. The surgeon and the surgeon’s assistants should avoid nicking or
scratching components.
▪ All implants should be used in the original form unless specifically stated. If applicable, any modification of the implant is
exclusively the surgeon’s responsibility.
▪ Only proper use of the specific accessory equipment for the implant ensures satisfactory implant placement. Before use,
verify instruments are intact and functioning completely properly.
▪ The Translace™ Spinal Tethering System tether and connector were designed to be used together and not separately.
▪ Translace™ Spinal Tethering System has not been tested for use with other manufacturers products.
▪ The malleable tip of the tether is made from commercially pure titanium, or medical grade stainless steel, and polyester.
This portion of the tether serves only to put the implant in place and should be removed once the connector is positioned
and is correctly placed under tension. This removal is performed by cutting the tip and extra tether and is described in the
surgical technique. This portion of the tether is not intended to be implanted.
▪ Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromium- molybdenum alloy may be used together.
Never use titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the
same construct.
ADDITIONAL PRECAUTIONS FOR PEDIATRIC PATIENTS
The implantation of tethering systems in pediatric patients should be performed only by experienced spinal surgeons with
specific training in the use of this tethering system in pediatric patients because this is a technically demanding procedure
presenting a risk of serious injury to the patient.
Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and proper selection and
placement of the implants are important considerations in the successful use of the system in pediatric patients.
Physician note: although the physician is the learned intermediary between the company and the patient, the important medical
information 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
Surgical implants are subject to repeated stresses in use, and their strength is limited by the need to adapt the design to the
size and shape of human bones. 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 implant 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.
DEVICE FIXATION
The Translace™ Spinal Tethering System contains tethers and connectors to be used for implantation with cleared rods and
implants of various diameters. Rods ranging from 4.5mm to 6.30mm, including CD Horizon™ Apex Rods and rods made of
titanium alloy or cobalt chrome may be used with the Translace™ Spinal Tethering System. The spinal tether consists of a
biocompatible polyester tether which connects through a titanium alloy connector around the lamina that is then fixated to the
rod. Once the tether connector is implanted and the rod is placed, the tether connector is attached to the rod, the tethers are
sequentially tightened, and the set screws are broken off. For self-breaking set screws, always hold the assembly with the
counter torque device. Tighten and break-off the head of the set screw to leave the assembly at optimum fixation security. After
the upper part of the self-breaking set screw is sheared off, further re-tightening is not necessary and not recommended. The
head part should not remain in the patient. After the upper part of the self breaking set screw is sheared off, re-adjustment is not
possible unless the set screw is removed and replaced with a new one.
PREOPERATIVE
▪ Only patients that meet the criteria described in the indications should be selected.
▪ Patient conditions and pre dispositions such as those addressed in the contraindications should be avoided.
▪ Care should be used when handling and storing implant components. Implants should not be scratched or otherwise
damaged. Implants and instruments should be protected during storage, especially from corrosive environments.
▪ An adequate inventory of implants should be available at the time of surgery; normally a quantity in excess of what is
expected to be used.
▪ 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.Translace™ Spinal Tethering System components (described in the DESCRIPTION section) are not to be
combined with components from another manufacturer.
▪ Instruments should be cleaned and sterilized before use. Additional sterile implants and instruments should be available in
case of an unexpected need.
INTRAOPERATIVE
▪ 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.
▪ Metallic tether connectors should not be bent. Use great care to ensure implant surfaces are not scratched or notched since
such actions may reduce the functional strength of the construct.
▪ Use an imaging system to facilitate surgery.
▪ Excessive force on the polyester tether during implantation and corrective procedures could lead to fracture of the lamina
and/or transverse process.
▪ After set screw break-off, and before wound closure, the excess tether should be cut from the connectors, leaving a 5mm
minimum tail.
▪ Bone graft must be placed in the area to be fused and graft material must extend from the upper vertebrae to the lower
vertebrae being fused.
▪ Bone cement should not be used because safety and effectiveness of bone cement has not been determined for spinal
uses, and this material will make removal of the components difficult or impossible. Heat generated from the curing process
may also cause neurologic damage and bone necrosis.
▪ Before closing the soft tissues, provisionally tighten the nuts or screws, especially screws or nuts that have a break-off
feature. Once this is completed, go back and firmly tighten all screws and nuts. Recheck the tightness of all nuts or screws
after finishing to ensure none loosened during the tightening of the other nuts or screws. Failure to do so may cause
loosening of the other components.
POSTOPERATIVE
The physician's postoperative directions and warnings to the patient, and the corresponding patient compliance, are extremely
important.
▪ 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, and/or breakage of
the device(s) are complications which may occur as a result of excessive or early weight-bearing or muscular activity.Risk
of bending, loosening, or breakage of a temporary internal fixation device during postoperative rehabilitation may be
increased if the patient is active, debilitated, or demented. 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 devices should not be exposed to mechanical
vibrations or shock 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 tobacco, use nicotine products, or consume alcohol or non-steroidals or anti-inflammatory
medications such as aspirin during the bone graft healing process.
▪ The patient should be advised of their inability to bend or rotate 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 the eventual bending, loosening, or breakage of the device(s). It is
important that immobilization of the spinal surgical site be maintained until firm bony union is established and confirmed by
roentgenographic examination. If a state of non-union persists or if the components loosen, bend, or break, the device(s)
should be revised or removed immediately before serious injury occurs. The patient must be adequately warned of these
hazards and closely supervised to ensure cooperation until bony union is confirmed.
▪ As a precaution, before patients with implants receive any subsequent surgery (such as dental procedures), prophylactic
antibiotics may be considered, especially for high-risk patients.
▪ The Translace™ Spinal Tethering System implants are temporary internal fixation devices. Internal fixation devices are
designed to stabilize the operative site during the normal healing process. After the spine is fused, these devices serve no
functional purpose and may be removed. While the final decision on implant removal is, of course, up to the surgeon and
patient, in most patients, removal is indicated because implants are not intended to transfer or support forces developed
during normal activities. If the device is not removed following completion of its intended use, one or more of the following
complications may occur: (1) corrosion, with localized tissue reaction or pain; (2) migration of implant position possibly
resulting in injury; (3) risk of additional injury from postoperative trauma; (4) bending, loosening, and breakage which could
make removal impractical or difficult; (5) pain, discomfort, or abnormal sensations due to the presence of the device; (6)
increased risk of infection; (7) bone loss due to stress shielding; and (8) potential unknown or unexpected long term effects
such as carcinogenesis. Implant removal should be followed by adequate postoperative management to avoid fracture, refracture, or other complications.
▪ Retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible. As with all
orthopedic implants, the Translace™ Spinal Tethering System implants should never be reused under any circumstances.
This device should be used only by physicians familiar with the device, its intended use, any additional instrumentation, and any
available surgical techniques.
PACKAGING
If devices are individually packaged, the packages for each of the implants and/or instruments should be intact upon receipt. If a
loaner or consignment system is used, all sets should be carefully checked for completeness and all components including
instruments should be carefully checked to ensure there is no damage prior to use. Damaged packages or products should not
be used and should be returned to Medtronic.
STERILE IMPLANTS
Implants are provided sterile and should only be used if they are marked sterile and clearly labeled as such in an unopened
sterile package provided by Medtronic. Only sterile products should be placed in the operative field. Implants should never be
reprocessed.
PRODUCT COMPLAINTS
To report any product problems, contact Medtronic.
MRI INFORMATION
The Translace™ Spinal Tethering System has not been evaluated for safety and compatibility in the MR environment. It has not
been tested for heating, migration, or image artifact in the MR environment. The safety of the Translace™ Spinal Tethering
System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.
FURTHER INFORMATION
Recommended directions for use of this system (surgical operative techniques) are available at no charge upon request. If
further information is required, contact Medtronic.
©2020 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
CAUTION: Federal law (USA) restricts these devices to
sale by or on the order of a physician.
Do not re-use
Batch code
Manufacturer
Catalogue number
For US audiences only
Sterilized using irradiation
Use-by date
Consult instructions for use at this website.
Medical device
Single sterile barrier system
Double sterile barrier system
Single sterile barrier system with protective packaging
outside
Single sterile barrier system with protective packaging
inside
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