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.
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