Medtronic 55751024560 Instructions for Use

CD Horizon™ Fenestrated Screw Set M708348B493E Rev. G

2020-09-29

IMPORTANT INFORMATION ON THE CD HORIZON™ FENESTRATED SCREW SET

PURPOSE

The CD Horizon™ Fenestrated Screw Set is intended to help provide immobilization and stabilization of spinal segments of the
thoracic, lumbar, or sacral spine.

DESCRIPTION

The CD Horizon™ Fenestrated Screw Set consists of a variety of cannulated screws. These screws contain a series of
fenestrations which allows polymethylmethacrylate (PMMA) bone cement (Medtronic HV-R™ Fenestrated Screw Cement or
Kyphon™ Xpede™ Bone Cement) to be injected into the treated site. This cement is used to augment screw fixation into the
pedicle in patients whose life expectancy is of insufficient duration to permit achievement of fusion.

These implants may also serve as traditional pedicle screws when used without bone cement in patients.
CD Horizon™ Fenestrated Screws are specifically designed to connect to appropriate rods and associated connecting

components contained within the CD Horizon™ Spinal System. Refer to the CD Horizon™ Spinal System package insert for
information regarding those implants. Care should be taken so the correct components are used in the spinal construct.

CD Horizon™ Fenestrated Screw Set implant components are fabricated from medical grade titanium and/or medical grade
titanium alloy and/or medical grade cobalt-chromium-molybdenum alloy. Never use stainless steel and titanium implant
components in the same construct.

To achieve best results, do not use CD Horizon™ Fenestrated Screw implants with components from any system other than the
CD Horizon™ Spinal System. As with all orthopedic and neurosurgical implants, CD Horizon™ Fenestrated Screw implants
should never be reused under any circumstances.

INDICATIONS

When used without cement, CD Horizon™ Fenestrated Screws (with or without Sextant™ or Longitude™ instrumentation) are
intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD­defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
spondylolisthesis, tumor and/or trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, or
lordosis), pseudarthrosis, and/or failed previous fusion.

Additionally, CD Horizon™ Fenestrated Screws may be used for immobilization and stabilization when used for trauma (e.g.,
fracture or dislocation) with the usage of bone graft material left to the surgeon’s discretion.

When used in conjunction with Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement, CD
Horizon™ Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a
limited time in patients with advanced stage tumors involving the thoracic, lumbar, or sacral spine in whom life expectancy is of
insufficient duration to permit achievement of fusion. CD Horizon™ Fenestrated Screws augmented with Medtronic HV-R™
Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement are for use at spinal levels where the structural integrity of the
spine is not severely compromised.

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.
▪ Pedicular/wall defects.
▪ An allergy or contraindication to PMMA cement (when used for the cement-related indications).

▪ 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.
▪ Any patient in which implant use would interfere with anatomical structures or expected physiological performance.
▪ Any patient unwilling to follow postoperative instructions.
▪ Any case not described in the indications.
▪ Any patient with a T-score of > -2.5 (when cement-augmentation is utilized in patients with advanced staged tumors).

ADDITIONAL CONTRAINDICATIONS

(SPECIFIC TO PATIENTS OUTSIDE SCOPE OF PMMA USAGE 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.

POTENTIAL ADVERSE EVENTS

All of the following adverse events associated with spinal 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, and/or breakage of any or all components.
▪ Foreign body (allergic) reaction to implants, debris, corrosion products (from crevice, fretting, and/or general corrosion)

including metallosis, staining, tumor formation, and/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 or instruments.
▪ Post-operative change in spinal curvature, loss of correction, height, or reduction.
▪ Infection.
▪ Dural tears, pseudomeningocele, fistula, persistent CSF leakage, or meningitis.
▪ Loss of neurological function (e.g. sensory and/or motor) including paralysis (complete or incomplete), dysesthesias,

hyperesthesia, anesthesia, paresthesia, appearance of radiculopathy, and/or development or continuation of pain,
numbness, neuroma, spasms, sensory loss, tingling sensation, and/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 and/or gastrointestinal system compromise.
▪ Scar formation possibly causing neurological compromise or compression around nerves and/or pain.
▪ Fracture, microfracture, resorption, damage, or penetration of any spinal bone (including the sacrum, pedicles, and/or

vertebral body).

▪ Herniated nucleus pulposus, disc disruption, or degeneration at, above, or below the level of surgery.
▪ Loss of or increase in spinal mobility or function.
▪ Inability to perform activities of daily living.
▪ Bone loss or decrease in bone density, possibly caused by stresses shielding.
▪ Ileus, gastritis, bowel obstruction, 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.

▪ Development of respiratory problems (e.g. pulmonary embolism, atelectasis, bronchitis, pneumonia, etc).
▪ Change in mental status.
▪ Death.

Serious adverse events, some with fatal outcomes, associated with the use of acrylic bone cements in the spine include
myocardial infarction, cardiac arrest, cerebrovascular accident, pulmonary embolism, and cardiac embolism. Although the
majority of these adverse events present early with the post-operative period, there have been some reports of diagnoses
beyond a year or more after the procedure.

Other reported adverse events for acrylic bone cements intended for use in the spine include leakage of the bone cement
beyond the site of its intended application with introduction into the vascular system resulting in embolism of the lung and/or
heart or other clinical sequelae.

Note: additional surgery may be necessary to correct some of these potential adverse events.

ADDITIONAL POTENTIAL ADVERSE EVENTS

(SPECIFIC TO PATIENTS OUTSIDE SCOPE OF PMMA USAGE INDICATIONS)

▪ Fracture, microfracture, resorption, damage or penetration of any spinal bone (including the sacrum, pedicles, and/or

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

▪ Retropulsed graft.
▪ Herniated nucleus pulposus, disc disruption or degeneration at, above, or below the level of surgery.