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.

▪ Non-union (or pseudarthrosis), delayed union, and mal-union.
▪ Cessation of any potential growth of the operated portion of the spine.
▪ Graft donor site complications including pain, fracture, or wound healing problems.
▪ Reproductive system compromise, including sterility, loss of consortium and sexual dysfunction.

ADDITIONAL POTENTIAL ADVERSE EVENTS FOR PEDIATRIC PATIENTS

(SPECIFIC TO PEDIATRIC PATIENTS OUTSIDE SCOPE OF PMMA USAGE INDICATIONS)

▪ Inability to use pedicle screw fixation due to anatomic limitations (pedicle dimensions, distorted anatomy).
▪ Pedicle screw malpositioning, with or without neurological or vascular injury.
▪ Proximal or distal junctional kyphosis.
▪ Pancreatitis.

WARNING

Safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant
mechanical instability or deformity requiring fusion with instrumentation. Safety and effectiveness of this device for any other
conditions are unknown. The implants are not prostheses. In the absence of fusion, instrumentation and/or one or more of its
components can be expected to pull out, bend, or fracture as a result of exposure to everyday mechanical stresses. Removal of
these implants used to treat spinal fractures is left to the discretion of the physician and the patient.

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.

The following should be noted as warnings and precautions specific to the instruments used in the injection of cement:

▪ Always use live imaging when injecting material.
▪ Cement leakage may cause tissue damage, nerve or circulatory problems, and other serious adverse events.

These risks may increase with the number of spinal levels where bone cement is used, and also with the volume of bone
cement used.

ADDITIONAL WARNINGS FOR PEDIATRIC PATIENTS

(SPECIFIC TO PEDIATRIC PATIENTS OUTSIDE SCOPE OF PMMA USAGE INDICATIONS)

Safety and effectiveness of this device have not been established for use as part of a growing rod construct. This device is only
intended to be used when definitive fusion is performed at all instrumented levels. Use of pedicle screw fixation in the pediatric
population may present additional risks when patients are of smaller stature and skeletally immature. Pediatric patients may
have smaller spinal structures (i.e. pedicle diameter or length) that may preclude the use of pedicle screws or increase the risk
of pedicle screw malpositioning and neurological or vascular injury. Patients not skeletally mature that undergo spinal fusion
procedures may have a reduced longitudinal spinal growth, or may be at risk for rotational spinal deformities (i.e. the “crankshaft
phenomenon”) due to continued differential growth of the anterior spine. Other adverse events related to pedicle screw fixation,
such as screw or rod bending, breakage, or loosening may also occur in pediatric patients. Pediatric patients may be at
increased risk for device-related injury because of their smaller stature.

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. 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.

Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and proper selection and
placement of implants are important considerations in the successful use of the system by the surgeon. Further, proper
selection and compliance of the patient will greatly affect results.

Refer to the Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement Instructions for Use for cement
related contraindications, potential adverse events, and warnings when using those specific cements.

ADDITIONAL PRECAUTIONS FOR PEDIATRIC PATIENTS

( SPECIFIC TO PEDIATRIC PATIENTS OUTSIDE SCOPE OF PMMA USAGE INDICATIONS)

Implantation of pedicle screw spinal systems in pediatric patients should be performed only by experienced spinal surgeons with
specific training in the use of pedicle screw spinal system implants 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 implants are important considerations in the
successful use of the system in pediatric patients. The selection of the proper size, shape, and design of the implant for each
patient is crucial to the safe use of this device in pediatric patients.

For US Audiences Only

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

IMPLANT SELECTION

Selection of proper size, shape, and design of the implant for each patient is crucial to success of the procedure. Metallic
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 metal 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.

PREOPERATIVE

▪ Only patients that meet the criteria described in the indications should be selected.
▪ Patient conditions and/or predispositions such as those addressed in the contraindications should be avoided.
▪ Care should be used in handling and storage of 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. CD
Horizon™ Spinal System components (described in the DESCRIPTION section) are not to be combined with components
from another manufacturer.

▪ Unless sterile packaged, all devices should be sterilized before use. Additional sterile components should be available in

case of an unexpected need.

INTRAOPERATIVE

▪ Extreme caution should be used around the spinal cord and nerve roots. Damage to the 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.
▪ Rods should not be repeatedly or excessively bent. Rods should not be reverse bent in the same location. Use great care to

ensure implant surfaces are not scratched or notched since such actions may reduce the functional strength of the
construct. If rods are cut to length, they should be cut in such a way as to create a flat, non-sharp surface perpendicular to
the midline of the rod. Cut the rods outside the operative field. Whenever possible, use pre-cut rods of the length needed.

▪ Refer to the CD Horizon™ Fenestrated Screw surgical technique for procedural steps prior to inserting CD Horizon™

Fenestrated Screws.

▪ When using these cement-augmented screws, connect the enclosed adapter to the screw, then connect the universal

handle to the adapter.

▪ Insert all of the screws. Use great care to ensure the implant surfaces are not scratched or notched, since such actions may

reduce the functional strength of the construct.

▪ Depending on the cement chosen, prepare in accordance with either the Medtronic HV-R™ Fenestrated Screw Cement or

Kyphon™ Xpede™ Bone Cement instructions for use. Refer to the Medtronic HV-R™ Fenestrated Screw Cement or
Kyphon™ Xpede™ Bone Cement, instructions for use for a complete review of all warnings and precautions. After the
cement is prepared, immediately load the cement injecting devices per individual system surgical techniques.

▪ It is recommended that a maximum of 1.8cc of cement be injected in the vertebral body for each CD Horizon™ Fenestrated

Screw from T11 to L5 and maximum of 0.8cc of cement be used for each CD Horizon™ Fenestrated Screw used from T1 to
T10 of the thoracic spine.

Note: the volume of cement used in CD Horizon™ Fenestrated Screw implants should ultimately be determined by the
surgeon based on the individual patient anatomy.

▪ Imaging systems must be used while cement is being delivered.
▪ Inject the cement slowly. If any extravasation is seen, stop the injection process immediately.
▪ Once the cement has been delivered, complete the procedure following the remaining steps outlined in the CD Horizon™

Fenestrated Screw Set surgical technique.

▪ Caution: do not over-tap or use a screw that is either too long or too large. Over-tapping, using an incorrectly sized screw,

or accidentally advancing the guidewire during tap or screw insertion, may cause nerve damage, hemorrhage, or the other
possible adverse events listed 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 may be placed in the area where fusion may be desired.
▪ To ensure maximum stability, two or more Crosslink™ plates or DTT Transverse Links on two bilaterally placed, continuous

rods should be used whenever possible.

▪ Before closing soft tissues, provisionally tighten (finger tighten) all nuts or non-cement augmented screws, especially

screws or nuts that have a break-off feature. Once this has been completed, go back and firmly tighten all non-cement
augmented 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, warnings to the patient, and corresponding patient compliance, are extremely

important.

▪ Detailed instructions on use and limitations of the device should be given to the patient. The patient must be warned that

bending, loosening, and/or breakage of 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 breakage 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.

▪ 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™ Fenestrated Screw implants are temporary internal fixation devices. Internal fixation devices are designed to

stabilize the operative site during the normal healing process.

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

all orthopedic implants, CD Horizon™ Fenestrated Screw components should never be reused under any circumstances.

PACKAGING

Devices can be supplied in sterile or non-sterile form. Packages for each of the components 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.

All products should be treated with care. Improper use or handling may lead to damage and/or possible improper functioning of
the device.

STERILIZATION

Unless marked sterile and clearly labeled as such in an unopened sterile package provided by the company, all implants must
be sterilized prior to use. Remove all packaging materials prior to sterilization. Only sterile products should be placed in the
operative field. Unless specified elsewhere, these products are recommended to be steam sterilized using one of the sets of
process parameters listed in Table 1.

Table 1: Sterilization cycle parameters for the US and its territories

Method Cycle Temperature Exposure time

Steam Dynamic-air-removal 270°F (132°C) 4 Minutes 30 Minutes
Steam Dynamic-air-removal 275°F (135°C) 3 Minutes 30 Minutes

For medical facilities located outside the US and its territories, some non-US health care authorities recommend sterilization
according to these parameters to minimize the risk of transmission of Creutzfeldt-Jakob disease, especially of surgical
instruments that could come into contact with the central nervous system.

Table 2: Sterilization cycle parameters for medical facilities outside the US and its territories

Method Cycle Temperature Exposure time

Steam Dynamic-air-removal 273°F (134°C) 4 Minutes 30 Minutes
Steam Dynamic-air-removal 273°F (134°C) 20 Minutes 30 Minutes

1

Minimum dry times were validated using sterilizers having vacuum drying capabilities. Drying cycles using ambient

atmospheric pressure may require longer dry times. Refer to the sterilizer manufacturer’s recommendations.

Note: because of the many variables involved in sterilization, each medical facility should calibrate and verify the sterilization
process (e.g. temperatures, times) used for their equipment.

Minimum dry time

Minimum dry time

1

1

PRODUCT COMPLAINTS

To report any product problems, contact Medtronic.

MRI INFORMATION

The CD Horizon™ Fenestrated Screw Set 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 CD Horizon™ Fenestrated Screw Set
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.

©2020 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

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

Non-sterile

For US audiences only

Consult instructions for use at this website.