Medtronic C01B Instructions for Use

Kyphon™ HV-R™ (High Viscosity,

M708348B154E Rev. F

Radiopaque) Bone Cement

2021-10-18

IMPORTANT INFORMATION ON KYPHON™ HV-R™ (HIGH VISCOSITY,
RADIOPAQUE) BONE CEMENT

Carefully read all instructions prior to use.

INDICATIONS FOR USE

Kyphon™ HV-R™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to
osteoporosis, cancer, or benign lesions using a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is also indicated
for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer
includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign
lesions include hemangioma and giant cell tumor. Pathological fracture may include a symptomatic vertebral body microfracture
(as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.

When used in conjunction with CD Horizon™ Fenestrated Screws, Kyphon™ HV-R™ Bone Cement is intended to restore
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 Kyphon™ HV-R™ Bone Cement are for use at spinal levels where the
structural integrity of the spine is not severely compromised.

DESCRIPTION

Kyphon™ HV-R™ Bone Cement is a polymethylmethacrylate (PMMA) that contains approximately 30% barium sulfate. It is
designed for delivery in a highly viscous state.

Table 1: Nominal Composition of Kyphon™ HV-R™ Bone Cement:
(Actual weight percentages of individual components will vary within accepted ranges.)

Powder (20g of sterile powder in a packet) Liquid (9.0g of sterile liquid in a vial)

Methylmethacrylate-styrene-copolymer 68.0% w/w Methylmethacrylate (monomer) 99.1% w/w
Barium sulfate 30.0% w/w N, N-dimethyl-p-toluidine 0.9% w/w
Benzoyl peroxide 2.0% w/w Hydroquinone 75 ppm

For US Audiences Only

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

CONTRAINDICATIONS

PMMA bone cement is contraindicated in the presence of active or incompletely treated infection at the site where bone cement
is to be applied for treatment of non-pathological, acute, traumatic fractures of the vertebra or sacrum, and in cases involving
either displaced sacral fractures or compromise of the sacral foramina.

WARNINGS

▪ The sterile Kyphon™ HV-R™ Bone Cement is designed and intended for one time use only. Do not re-sterilize and/or re-

use. Sterility is assured only if the unit container is not damaged.

▪ Maintain aseptic surgical technique to prevent possible infection including treatment site infection.
▪ Monitor patients carefully for any change in blood pressure during and immediately following the application of bone

cement. Adverse patient reactions affecting the cardiovascular system, including Bone Cement Implantation Syndrome
(BCIS), have been associated with the use of bone cements. Hypotensive reactions have occurred between 10 and 165
seconds following application of bone cement. The reactions lasted from 30 seconds to 5 or more minutes. Some have
progressed to cardiac arrest. Patients should be monitored carefully for any change in blood pressure during and
immediately following the application of bone cement, especially those potentially at increased risk for peri-operative death
including elderly patients, patients with underlying cardiac or pulmonary compromise, and patients being treated for multiple
vertebral body fractures in one procedure.

▪ 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.

▪ Caution should be exercised during the mixing of the two components to prevent excessive exposure to concentrated

vapors of the monomer, which may produce irritation of the respiratory tract, eyes, and possibly liver.

▪ Polymerization of bone cement is an exothermic reaction which occurs while the cement is hardening in situ. According to

the ISO 5833 standard, the temperature can be as high as 90°C ± 5°C. Released heat may damage bone or other tissues
surrounding implants.

▪ The liquid component is a powerful lipid solvent. It should not be allowed to come into contact with rubber or latex gloves.

Should contact occur, gloves may dissolve and tissue damage may occur. Wearing a second pair of gloves and adherence
to mixing instructions may diminish the possibility of hypersensitivity reactions. Mixed bone cement should not make contact
with the gloved hand until bone cement is being tested for the consistency of dough.

▪ Personnel wearing permeable contact lenses should not be near or involved in mixing bone cement. Soft contact lenses are

permeable.

▪ Handling characteristics of bone cement are affected by operating room conditions including room temperature,

temperature of cement components prior to mixing, humidity, geometry of the mixing apparatus, time spent mixing, and
geometry of the delivery device. Changes in one or more of these conditions can alter handling characteristics of bone
cement, including:

▪ Handling period - time it takes for the bone cement to reach the doughy state. Cement has reached the doughy state

when it no longer sticks to surgical gloves.

▪ Working period - time bone cement remains in the doughy state and can be delivered.
▪ Hardening period - time needed for bone cement to harden or until it can no longer be delivered.

Users must be aware of these factors and adjust technique to account for variability in operating room conditions.

▪ Avoid over-pressurization of bone cement and do not insert bone cement into the cavity of the vertebral body until bone

cement has reached the doughy state. Cement has reached the doughy state when it no longer sticks to surgical gloves.
Maintain patient positioning until the end of the polymerization process. Failure to do so may lead to extravasation of bone
cement beyond the site of its intended application and may or could damage surrounding tissues.

▪ Safety of bone cement in pregnant women or in children was not established. Bone cement may adversely affect bone

growth and fetal health.

▪ Difficulty in swallowing and blistering of the throat, alleged to be an allergic reaction to the use of bone cement, have also

been reported.

▪ Do not mix more than one vial of liquid and one packet of powder together at any one time. Never modify ratios between

liquid and solid components. Doing so can affect bone cement properties including handling characteristics.

▪ Long-term follow-up is advised for all patients on a regularly scheduled basis. Inadequate filling or unanticipated

postoperative events may affect stability of bone cement and/or the bone cement-bone interface. A fibrous tissue layer may
develop between cement and the bone and loosening of bone cement may occur leading to failure.

▪ Kyphon™ HV-R™ Bone Cement is provided in finished form with all necessary components for use. The addition of a

radiopacifier (e.g. barium, antibiotics, or other drugs or materials) to Kyphon™ HV-R™ Bone Cement is not recommended.
Never add other substances or foreign bodies to the acrylic resin. Safety and effectiveness of adding such drugs or
materials was not evaluated and may cause patient harm.

▪ Modifying polymerization time by either warming or cooling bone cement and/or associated delivery devices was not tested

and could affect bone cement properties including handling characteristics.

PRECAUTIONS

▪ Keep the product at a temperature of 23 ± 1°C for a period of 24 hours prior to use.
▪ Never deliver bone cement into the vertebral body without the use of high quality fluoroscopic guidance capable of

visualizing movement of bone cement.

▪ Only physicians thoroughly trained in pedicle screw placement, and the surgical use of bone cement and balloon

kyphoplasty should use Kyphon™ HV-R™ Bone Cement. Users should have specific training and be familiar with
properties, handling characteristics, and application of bone cement and adhere to instructions for use.

▪ Do not use after the expiration date printed on the package. The device may not be safe or effective beyond its expiration

date.

▪ Do not use if package is opened or damaged because product integrity including sterility may be compromised.
▪ Do not use damaged products. Prior to use, inspect the packaging and product to verify no damage has occurred.
▪ Follow mixing and handling instructions to avoid contact dermatitis. Strict adherence to instructions for mixing powder and

liquid components may reduce the incidence of this complication.

▪ Adequately ventilate the operating room to eliminate as much monomer vapor as possible. Liquid monomer is highly volatile

and flammable. Ignition of monomer fumes caused by use of electrocautery devices in surgical sites near freshly implanted
bone cements has been reported.

▪ Dispose of the polymer component in an authorized waste facility. The liquid component can be evaporated under a well-

ventilated hood or absorbed by an inert material and transferred in a suitable container for disposal.

▪ Use imaging techniques during needle placement and during injection. Extravasation can occur during cement injection if

the needle is in an artery or vein, or if unseen microfractures are prevalent. Embolization can also occur if the needle is
placed in an artery or vein. Cement extravasation may cause tissue damage, nerve or circulatory problems, and increase
risk for future fractures.

▪ If bone cement is seen outside of the vertebral body/sacrum or in the circulatory system during the procedure, immediately

stop the injection.

▪ Ensure immediate surgical support is available for urgent surgery if required.

ADVERSE EVENTS

Serious adverse events, some with fatal outcome, associated with the use of acrylic bone cements in the spine or intended for
vertebroplasty or kyphoplasty include:

▪ Cardiac arrest.
▪ Cerebrovascular accident.
▪ Myocardial infarction.
▪ Pulmonary embolism.
▪ Cardiac embolism.

Although the majority of these adverse events present early within the post-operative period, there have been some reports of
diagnoses beyond a year or more after the procedure.

Other reported adverse events relevant to the anatomy being treated with acrylic bone cements intended for use in spine, or
vertebroplasty or kyphoplasty include:

▪ Leakage of bone cement beyond the site of its intended application with introduction into the vascular system resulting in,

but not limited to, embolism of the lung and/or heart or other clinical sequelae.

▪ Deep or superficial wound infection.
▪ Fistula.
▪ Hematoma.
▪ Hemorrhage.
▪ Heterotopic new bone formation.
▪ Extravasation of bone cement beyond the site of its intended application potentially resulting in but not limited to:

▪ compression or irritation of nerve structures, such as the spinal cord or nerve roots, causing radiculopathy, parasthesia,

paraplegia or paralysis and/or;

▪ introduction into the vascular system resulting in embolism of the lung and/or heart or other clinical sequelae
▪ Pyrexia due to allergy to bone cement.
▪ Short-term conduction irregularities.
▪ Thrombophlebitis.
▪ Transitory fall in blood pressure.
▪ Migration of hardened bone cement bolus.
▪ Extravasation of bone cement into sacral foramen or sacroiliac joint potentially resulting in, but not limited to:

▪ compression or irritation of sacral nerve structures causing radicular pain

▪ sacroiliac joint dysfunction

INSTRUCTIONS FOR THE PREPARATION AND CLINICAL USE OF Kyphon™ HV-R™ BONE
CEMENT

Timing for the Preparation and Application of Kyphon™ HV-R™ Bone Cement

Handling characteristics of bone cements are affected by operating room conditions, including room temperature, temperature
of cement components prior to mixing, humidity, geometry of the mixing apparatus, time spent mixing, and geometry of the
delivery device. Changes in one or more of these conditions can alter handling characteristics of bone cement, including:

▪ Handling period - time it takes for bone cement to reach the doughy state. Cement has reached the doughy state when it no

longer sticks to surgical gloves.

▪ Working period - time bone cement remains in the doughy state and can be delivered.
▪ Hardening period - time needed for bone cement to harden or until it can no longer be delivered.

Users must be aware of these factors and adjust technique to account for variability in operating room conditions. Under specific
conditions in our laboratory, Kyphon™ HV-R™ Bone Cement had the following dough time, hardening time, and working period,
using Kyphon™ Bone Filler Devices, which allowed sufficient time for minimally invasive surgical introduction of bone cement.

Average Room Temperature at Start
of Mixing (±1°C)

15 23.8 40.0 16.2
19 14.0 33.8 19.8
22 9.5 17.9 8.4
23 8.9 19.3 10.4
25 7.6 18.4 10.8
29 4.6 12.3 7.7

Lower temperatures or other changes in operating room conditions can increase handling, doughy (working), and hardening
periods. Conversely, higher temperatures or other changes in operating room conditions can decrease handling, doughy
(working), and hardening periods.

Average Dough Time
(minutes)

Average Hardening Time
(minutes)

Average Working Period
(minutes)

Handling Characteristics of Kyphon™ HV-R™ Bone Cement at 23±1°C in our Laboratory

Period Activity Approximate Cumulative Time From Initiation of Mixing*

Mixing Mix liquid and powder 0-2 minutes
Handling Transfer into delivery system 2-8 minutes
Working (doughy state) Fill cavity in vertebral body 8-16 minutes
Hardening Wait before completing procedure 16-20 minutes

Note: these cumulative time periods vary depending on temperature and other factors. For example, the colder the environment,
the longer the time necessary for the cement to develop the required doughy consistency. Warmer temperatures require more
rapid preparation and handling (see Figure 1). Ensure cement’s viscosity is high enough (doughy) before delivery. Cement has
reached the doughy state when it no longer sticks to surgical gloves.

* These times are based on cement prepared by Medtronic. Times were obtained from bone cement mixed in a Kyphon™ Mixer
and delivered through a Kyphon™ Bone Filler Device (inner diameter = 0.114”). Times may vary when other mixing methods,
delivery devices, and/or vacuum are used.

Dough time
Hardening time

Time (min)

Temperature (°C)

Figure 1. The effect of room temperature on handling characteristics of Kyphon™ HV-R™ Bone Cement is shown in Figure 1.

At room temperatures of 15, 19, 23, 25 and 29°C, units of Kyphon™ HV-R™ Bone Cement were mixed in a Kyphon™ Mixer
and transferred to Kyphon™ Bone Filler Devices (BFD, size 3). Dough time and hardening time were measured. The dashed
line represents dough time (when dispensed cement no longer sticks to a surgical glove) and the solid line represents hardening
time (when cement is too hard to dispense).

Preparation Procedures

▪ Per the note above, temperature can affect handling of cement. Prior to use, keep the product at a temperature of 23 ± 1°C

for a period of 24 hours.

▪ Prior to use, Kyphon™ HV-R™ Bone Cement packaging should be examined for damage and the presence of all required

components.

▪ Maintain aseptic transfer surgical technique to prevent possible infection.
▪ Maintain strict adherence to instructions for mixing powder and liquid to prevent possible dermatitis from the liquid monomer

during handling.

▪ Ensure inner package is undamaged, powder is not discolored (yellow or brown), and liquid is not syrupy. These conditions

indicate the product was not stored correctly.

▪ Ensure preparation accessories are specifically compatible with bone cement product.
▪ Do not open the vial of liquid over the mixing bowl to avoid risk of glass fragments entering the dough.
▪ Never add other substances or foreign bodies to acrylic resin. Never modify ratios between liquid and solid components.
▪ Care should be taken when mixing liquid and powder components so the entire contents of the vial and packet are used.

Liquid monomer and powder component should be thoroughly mixed.

Mixing Procedure:

1. Always use sterile technique when mixing bone cement.

2. Open powder packet and break open the vial. Immediately combine powder and liquid into a mixing bowl or Kyphon™

Mixer.

3. When using the Kyphon™ Mixer, follow Kyphon™ Mixer instructions for use.

4. When mixing by hand, mix with a spatula until ingredients are smoothly and uniformly combined (approximately one minute

or longer as necessary). The liquid must moisten all the powder. Use the spatula to carefully work any lumps of non­moistened powder into the overall mass of moist dough.

5. After powder and liquid are thoroughly mixed, the transfer of the mixture into a cement delivery device(s) may begin. Allow
for complete dissolution of powder into liquid prior to transferring the bone cement into the cement delivery device(s). This
can take up to approximately 8 minutes after the start of mixing.

Clinical Application Procedures (Cementoplasty or Sacroplasty)

When bone cement is in a doughy state, it has reached the appropriate level of viscosity and is ready to be placed into the
pathological fracture. Do not insert bone cement into the vertebral body until bone cement has reached the doughy state.
Cement has reached the doughy state when it no longer sticks to surgical gloves.

1. Before delivery, dispense a small sample of bone cement from the delivery device to ensure proper viscosity. Bone cement
is not ready to deliver until it does not drip from the cement delivery device, does not stick to surgical gloves, and has lost its
sheen.

2. Delivery of bone cement into the vertebral body should begin in the anterior or central region of the vertebral body. Continue
by allowing bone cement to flow into the posterior area without moving the delivery device posteriorly. Care should be taken
to avoid placing the delivery device against the anterior cortex.

3. While bone cement hardens, it is important to maintain patient positioning until the end of the polymerization or hardening
process.

Recommended directions for use of this system (surgical operative techniques) are available at no charge upon request.

Clinical Application Procedures (Pedicle Screw Augmentation)

When bone cement is in a doughy state, it has reached the appropriate level of viscosity and is ready to be placed into the CD
Horizon™ Fenestrated Screw. Do not insert bone cement into the fenestrated screw until bone cement has reached the doughy
state. Cement has reached the doughy state when it no longer sticks to surgical gloves.

1. Before delivery, dispense a small sample of bone cement from the delivery device to ensure proper viscosity. Bone cement
is not ready to deliver until it does not drip from the cement delivery device, does not stick to surgical gloves, and has lost its
sheen.

2. When viscosity is correct, cement can be injected following the screw surgical technique.

3. While bone cement hardens, it is important to maintain patient positioning until the end of the polymerization or hardening

process.

HOW SUPPLIED

Kyphon™ HV-R™ Bone Cement is supplied sterile. The powder and package are sterilized with gamma radiation. The liquid is
sterilized using filtration and is contained in a glass vial. The outside of the glass vial is sterilized with ethylene oxide gas. This
device is intended for single use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization
may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in
patient injury, illness, or death. Do not use if package is open or damaged.

STORAGE

Kyphon™ HV-R™ Bone Cement should be stored in its original shipping materials. Proper care should be taken to ensure
Kyphon™ HV-R™ Bone Cement will not be damaged. Store below 25°C and away from sunlight.

LIMITATION OF LIABILITY

Medtronic will not be responsible for any direct, indirect, consequential, or exemplary damages resulting from reuse of
Kyphon™ HV-R™ Bone Cement.

In no event shall Medtronic be liable for any direct, indirect, incidental, consequential, or exemplary damages arising out of or in
connection with Kyphon™ HV-R™ Bone Cement, based upon breach of contract (including breach of warranty).

PRODUCT COMPLAINTS

For product problems, contact Medtronic.

FURTHER INFORMATION

Recommended directions for use of this system (surgical operative techniques) are available at no charge upon request. If
further information is required, contact Medtronic.

©2021 Medtronic Sofamor Danek USA, Inc. All rights reserved.

MANUFACTURED FOR:

Medtronic Sofamor Danek USA, Inc.

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

901 396 3133 (Outside USA)

Fax: [phone]

EXPLANATION OF SYMBOLS

Flammable

Sterilized using ethylene oxide (Liquid Package)

Sterilized using aseptic processing techniques (Liquid)

Sterilized using irradiation (Powder)

Manufacturer

Date of manufacture

Batch Code

Catalog number

Do not re-use

Use-by date

Keep away from sunlight

Caution, Consult Accompanying Documents

Do not resterilize

25°C

Store below 25°C

Do not use if package is damaged and consult instructions
for use

For US audiences only

Consult instructions for use at this website.

*Single sterile barrier system

Double sterile barrier system

Single sterile barrier system with protective packaging
inside

Single sterile barrier system with protective packaging
outside

*Single barrier packaging systems may not contain a
sterile barrier system symbol. Per ISO 11607-1, a symbol
is only required if more than one barrier is present.