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