Medtronic 5530620 Instructions for Use

CD Horizon™ Astute™ Spinal System M708348B498E Rev. A

2019-10-16

IMPORTANT INFORMATION ON THE CD HORIZON™ ASTUTE™ SPINAL SYSTEM

PURPOSE

The CD Horizon™ Astute™ Spinal System is intended to help provide immobilization and stabilization of spinal segments as an
adjunct to fusion of the lumbar or sacral spine.

DESCRIPTION

The CD Horizon™ Astute™ Spinal System consists of a variety of sizes of rods, as well as set screws, which are used with
bone screws from the CD Horizon™ Solera™ Spinal System, to create a variety of rigidly locked configurations, with each
construct being tailored to the individual case.

CD Horizon™ Astute™ Spinal System implant components are fabricated from medical grade titanium alloy, tantalum, or
polyetheretherketone (PEEK). No warranties, express or implied, are made. Implied warranties of merchantability and fitness for
a particular purpose or use are specifically excluded.

Medical grade titanium, titanium alloy, or medical grade cobalt-chromium-molybdenum alloy may be used together. Never use
titanium, titanium alloy, or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct. Only
use set screws designed for use with CD Horizon™ Astute™ rods.

PEEK implants may be used with titanium alloy or cobalt-chromium-molybdenum alloy implants. CD Horizon™ Astute™ Spinal
System rods are not to be used with Crosslink™ plates, fixed angle screws, sagittally adjusting screws, or in pediatric patients.

To achieve best results, do not use CD Horizon™ Astute™ Spinal System implant components with components from any other
system or manufacturer unless specifically allowed to do so in this or another Medtronic document. As with all orthopaedic and
neurosurgical implants, no component of the CD Horizon™ Astute™ Spinal System should ever be reused under any
circumstances.

INDICATIONS

The CD Horizon™ Astute™ Spinal System is intended to provide for posterior, supplemental fixation when used with an
interbody fusion cage for patients diagnosed with degenerative disc disease (DDD- defined as back pain of discogenic origin
with degeneration of the disc confirmed by history and radiographic studies). These DDD patients may also have up to Grade 1
spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 –
S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is
not intended for stand-alone use.

CONTRAINDICATIONS

Contraindications include:

▪ Active infectious process or significant risk of infection (immunocompromise).
▪ Signs of local inflammation.
▪ Fever or leukocytosis.
▪ Morbid obesity.
▪ Pregnancy.
▪ Mental illness.
▪ Grossly distorted anatomy caused by congenital abnormalities.
▪ Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery such as the

presence of 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 not needing a bone graft and fusion.
▪ Any case where implant components selected for use would be too large or too small to achieve a successful result.
▪ Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
▪ Any patient in which implant use would interfere with anatomical structures or expected physiological performance.
▪ The CD Horizon™ Astute™ Spinal System is specifically contraindicated for use in pediatric patients.
▪ Any patient unwilling to follow postoperative instructions.
▪ Any case not described in the indications.

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.
▪ Spondylolisthesis above Grade 2.
▪ Scoliosis.

POTENTIAL ADVERSE EVENTS

All adverse events associated with spinal fusion surgery without instrumentation are possible. With instrumentation, a listing of
potential adverse events includes:

▪ Early or late loosening of any or all components.
▪ Disassembly, bending, or breakage of any or all components.
▪ Foreign body (allergic) reaction to implants, debris, corrosion products (from crevice, fretting, or general corrosion) including

metallosis, staining, tumor formation, or autoimmune disease.

▪ Pressure on the skin from component parts in patients with inadequate tissue coverage over the implant possibly causing

skin penetration, irritation, fibrosis, necrosis, or pain.

▪ Bursitis.
▪ Tissue or nerve damage caused by improper positioning and placement of implants.
▪ Post-operative change in spinal curvature, loss of correction, height, or reduction.
▪ Infection.
▪ Dural tears, pseudomeningocele, fistula, persistent CSF leakage, and/or meningitis.
▪ Loss of neurological function (e.g. sensory or motor) including paralysis (complete or incomplete), dysesthesias,

hyperesthesia, anesthesia, paresthesia, appearance of radiculopathy, or the development or continuation of pain,
numbness, neuroma, spasms, sensory loss, tingling sensation, or visual deficits.

▪ Cauda equina syndrome, neuropathy, neurological deficits (transient or permanent), paraplegia, paraparesis, reflex deficits,

irritation, arachnoiditis, and/or muscle loss.

▪ Urinary retention, loss of bladder control, or other types of urological system compromise.
▪ Scar formation possibly causing neurological compromise or compression around nerves or pain.
▪ Fracture, microfracture, resorption, damage, or penetration of any spinal bone (including the sacrum, pedicles, or vertebral

body) or bone graft or bone graft harvest site at, above, or below the level of surgery.

▪ Retropulsed graft.
▪ Herniated nucleus pulposus, disc disruption, or degeneration at, above, or below the level of surgery.
▪ Non-union (or pseudarthrosis), delayed union, or mal-union.
▪ Loss of or increase in spinal mobility or function.
▪ Inability to perform the activities of daily living.
▪ Bone loss or decrease in bone density possibly caused by stress shielding.
▪ Graft donor site complications including pain, fracture, or wound healing problems.
▪ Ileus, gastritis, bowel obstruction or loss of bowel control, or other types of gastrointestinal system compromise.
▪ Hemorrhage, hematoma, occlusion, seroma, edema, hypertension, embolism, stroke, excessive bleeding, phlebitis, wound

necrosis, wound dehiscence, damage to blood vessels, or other types of cardiovascular system compromise.

▪ 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 potential adverse events.

WARNINGS

The safety and effectiveness of pedicle screw spinal systems were established only for spinal conditions with significant
mechanical instability or deformity requiring fusion with instrumentation. These conditions are DDD of the lumbar and sacral
spine up to Grade 1 spondylolisthesis. The safety and effectiveness of this device for any other conditions are unknown.
Implants are not prostheses. This device is not intended to be used for spinal stabilization without fusion. In the absence of
fusion, the instrumentation or one or more of its components can be expected to pull out, bend, or fracture as a result of
exposure to every day mechanical stresses.

A device that has been implanted should never be reused, reprocessed, or resterilized under any circumstances. Sterile
packaged devices should also never be resterilized. Reuse, reprocessing, or resterilization may compromise the structural
integrity of these implants and create a risk of contamination of the implants which could result in patient injury, illness, or death.

PRECAUTIONS

Implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in
the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury
to the patient.

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 the results. This 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, or breakage of
the device(s) will eventually occur.

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. Further, the proper selection and
compliance of the patient will greatly affect the results. Patients who smoke were shown to have an increased incidence of non­unions. These patients should be advised of this fact and warned of this consequence. Obese, malnourished, or alcohol abuse
patients are poor candidates for spine fusion. In addition, patients with poor muscle and bone quality or nerve paralysis 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.

Use great care to ensure the implant surfaces are not scratched or notched since such actions may reduce the functional
strength of the construct. CD Horizon™ Astute™ rods are pre-bent and not designed to be cut or contoured. If a section of rod
containing a radiographic marker is cut from the rod, it will no longer be possible to visualize that end of the rod under
radiographic examination.

The CD Horizon™ Astute™ Spinal System has a dedicated set screw that must not be used with CD Horizon™ Solera™
titanium, titanium alloy, or medical grade cobalt-chromium-molybdenum rods. CD Horizon™Astute™ rods are intended to be
used only with the associated CD Horizon™ Solera™ multi-axial screws (MAS) and are not to be used with other components
from the CD Horizon™ Spinal System (e.g. hooks, rod-to-rod connectors, crosslinks, offset connectors). Astute™ rods are also
not intended to be attached to larger constructs. The use of CD Horizon™ Astute™ rods with fixed angle screws (FAS) and
sagittal adjusting screws (SAS) are not recommended.

IMPLANT SELECTION

Selection of the proper size, shape, and design of the implant for each patient is crucial to the success of the procedure.
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 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 CD Horizon™ Astute™ Spinal System contains PEEK implants of various sizes, set screws, and instruments used to
facilitate the implantation of the device.

CD Horizon™ Astute™ PEEK rods are not to be used with in pediatric patients. These PEEK rods are only to be used with the
associated CD Horizon™ Solera™ MAS screws as well as interbody fusion devices in the anterior spinal column.

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 in the handling and storage of implant components. Implants should not be scratched or otherwise

damaged. Implants 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 and variety 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. CD Horizon™ Astute™ Spinal System components (described in the DESCRIPTION section) are not to be
combined with the components from another manufacturer.

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 implant components may cause injury to the patient or operative personnel.
▪ Use an imaging system to facilitate surgery.
▪ Caution: do not over-tap or use a screw that is either too long or too large. Over-tapping and/or using an incorrectly sized

screw may cause nerve damage, hemorrhage, or the other possible adverse events listed elsewhere in this package insert.
If screws are being inserted into spinal pedicles, use as large a screw diameter as will fit into each pedicle.

▪ Bone graft must be placed in the area to be fused and graft material must extend from the upper vertabrae to the lower

vertebrae being fused.

▪ Before closing soft tissues, provisionally tighten (finger tighten) all set screws. Once this is complete, go back and apply

sufficient torque to break off set screws. Recheck all set screws to ensure none have loosened during final tightening.
Failure to do so may cause loosening of other components.

POSTOPERATIVE

The physician's postoperative directions, 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. As weight-bearing is

recommended or required prior to firm bony union, the patient must be warned that bending, loosening, or breakage of the
device(s) are complications which may occur as a result of excessive or early weight-bearing or muscular activity. The risk
of bending, loosening, or breaking of a temporary internal fixation device during postoperative rehabilitation may be
increased if the patient is active, or if the patient is 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, consume alcohol, 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. The patient should be 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 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.

▪ CD Horizon™ Astute™ Spinal 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 up to the surgeon and patient, in
most patients, removal is recommended because the 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)
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, re-fracture,
or other complications.

▪ Any retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible.

PACKAGING

Implants are supplied in a sterile form. Packages should be intact upon receipt. Once the seal on the sterile package has been
broken, the product should not be re-sterilized. 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.

STERILIZATION

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 the company. Only sterile products should be placed in the operative field.

PRODUCT COMPLAINTS

For product problems, contact Medtronic.

MRI INFORMATION

The CD Horizon™ Astute™ Spinal System has not been evaluated for safety, heating, migration, or compatibility in the
magnetic resonance environment. It was not tested for heating, migration, or image artifact in the MR environment. The safety
of the CD Horizon™ Astute™ Spinal 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 needed or required, contact Medtronic.

©2019 Medtronic Sofamor Danek USA, Inc. All rights reserved.

Medtronic Sofamor Danek USA, Inc.

1800 Pyramid Place
Memphis, TN 38132
Telephone: [phone] (USA)

901 396 3133 (Outside USA)

Fax: [phone]

EXPLANATION OF SYMBOLS

Do not re-use

Batch code

Manufacturer

Catalogue number

Sterilized using irradiation

Use-by date

Caution

Do not use if package is damaged

Consult instructions for use at this website.

For US audiences only

CAUTION: Federal law (USA) restricts these devices to
sale by or on the order of a physician.