Medtronic HV-R™ Fenestrated Screw
M708348B496E Rev. B
Cement
2017-12-14
IMPORTANT INFORMATION ON THE MEDTRONIC HV-R™ FENESTRATED SCREW
CEMENT
DESCRIPTION
Medtronic HV-R™ Fenestrated Screw 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 Medtronic HV-R™ Fenestrated Screw 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
INDICATIONS
When used in conjunction with CD HORIZON™ Fenestrated Screws, Medtronic HV-R™ Fenestrated Screw Cement is 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 and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of
fusion. Medtronic HV-R™ Fenestrated Screw Cement is limited to use at spinal levels where the structural integrity of the spine
is not severely compromised.
STERILE
Medtronic HV-R™ Fenestrated Screw 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 resterilize. Do not use if package is open or damaged.
CONTRAINDICATIONS
Medtronic HV-R™ Fenestrated Screw Cement is contraindicated in the presence of active or incompletely treated infection at
the site where the bone cement is to be applied.
WARNINGS
▪ The Medtronic HV-R™ Fenestrated Screw 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 and have 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 utilized, 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 the concentrated
vapors of the monomer, which may produce irritation of the respiratory tract, eyes, and possibly the liver.
▪ Polymerization of the bone cement is an exothermic reaction, which occurs while the cement is hardening in situ. The
released heat may damage bone or other tissues surrounding the implant.
▪ 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, the gloves may dissolve and tissue damage may occur. Wearing a second pair of gloves and
adherence to the mixing instructions may diminish the possibility of hypersensitivity reactions. The mixed bone cement
should not make contact with the gloved hand until the bone cement is being tested for the consistency of dough.
▪ Personnel wearing permeable contact lenses should not be near or involved in mixing the bone cement. Note: soft contact
lenses are permeable.
▪ The handling characteristics of bone cements are affected by operating room conditions, including the room temperature,
temperature of the cement components prior to mixing, humidity, the geometry of the mixing apparatus, time spent mixing,
and the geometry of the delivery device. Any change in one or more of these conditions can alter the handling
characteristics of the bone cement, including the following:
▪ Handling period - the time it takes for the bone cement to reach the doughy state. The cement has reached the doughy
state when it no longer sticks to surgical gloves.
▪ Working period - the time the bone cement remains in the doughy state and can be delivered.
▪ Hardening period - the time it takes for the bone cement to harden or until it can no longer be delivered.
The user must be aware of these factors and adjust technique to account for variability in operating room conditions.
▪ Avoid over-pressurization of the bone cement and do not insert the bone cement into the cavity of the vertebral body until
the bone cement has reached the doughy state. The 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 the bone cement beyond the site of its intended application and may or could damage the surrounding
tissues.
▪ 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 the ratios between
the liquid and solid components. Doing so can affect bone cement properties, including handling characteristics.
▪ Inadequate filling or unanticipated postoperative events may affect the stability of the bone cement and/or the bone cement-
bone interface. A fibrous tissue layer may develop between the cement and the bone, and loosening of the bone cement
may occur, leading to failure.
▪ Medtronic HV-R™ Fenestrated Screw Cement is provided in finished form with all the necessary components for use. The
addition of radiopacifier (e.g. barium, antibiotics, or other drugs or materials) to Medtronic HV-R™ Fenestrated Screw
Cement is not recommended. Never add other substances or foreign bodies to the acrylic resin. The safety and
effectiveness of adding such drugs or materials has not been evaluated and may cause patient harm.
▪ Modifying the polymerization time by either warming or cooling the bone cement and/or associated delivery devices has not
been tested and could affect bone cement properties, including handling characteristics.
PRECAUTIONS
▪ Store product below 25°C. 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 fenestrated screw 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 should use these
devices. The operator should have specific training and be familiar with the properties, handling characteristics, and
application of the bone cement and adhere to the 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 that no damage has occurred.
▪ Follow the mixing and handling instructions to avoid contact dermatitis. Strict adherence to the instructions for mixing the
powder and liquid components may reduce the incidence of this complication.
▪ Adequately ventilate the operating room to eliminate as much monomer vapor as possible. The 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.
For US Audiences Only
Caution: federal law (USA) restricts these devices to sale by or on the order of a physician.
ADVERSE EVENTS
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, but not limited to, embolism of
the lung and/or heart or other clinical sequelae.
Other reported adverse events relevant to the anatomy being treated with acrylic bone cements include:
▪ Deep or superficial wound infection.
▪ Fistula.
▪ Hematoma.
▪ Hemorrhage.
▪ Extravasation of bone cement 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, 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.
PREPARATION AND USE
Timing for Preparation and Application
The handling characteristics of bone cements are affected by operating room conditions, including the room temperature,
temperature of the cement components prior to mixing, humidity, the geometry of the mixing apparatus, time spent mixing, and
the geometry of the delivery device. Any change in one or more of these conditions can alter the handling characteristics of the
bone cement, including the following:
▪ Handling period - the time it takes for the bone cement to reach the doughy state (the cement has reached the doughy state
when it no longer sticks to surgical gloves).
▪ Working period - the time the bone cement remains in the doughy state and can be delivered.
▪ Hardening period - the time it takes for the bone cement to harden or until it can no longer be delivered.
The user must be aware of these factors and adjust technique to account for variability in operating room conditions.
Under specific conditions, Medtronic HV-R™ Fenestrated Screw 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 the 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 the handling, doughy (working), and hardening
periods. Conversely, higher temperatures or other changes in operating room conditions can decrease the handling, doughy
(working), and hardening periods.
Average Dough Time
(minutes)
Average Hardening Time
(minutes)
Average Working Period
(minutes)
Handling Characteristics of Medtronic HV-R™ Fenestrated Screw 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 will 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 the cement’s viscosity is high enough (doughy) before
delivery begins. The 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 the handling characteristics of Medtronic HV-R™ Bone Cement is shown in the
above time vs. temperature graph. At room temperatures of 15°C, 19°C, 23°C, 25°C and 29°C, units of Medtronic HV-R™
Fenestrated Screw 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
▪ Per the note above, temperature can affect the handling of the cement. Prior to use, it is advised to keep the product at a
temperature of 23±1°C for a period of 24 hours.
▪ Prior to use, Medtronic HV-R™ Fenestrated Screw 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 the instructions for mixing the powder and liquid to prevent possible dermatitis from the liquid
monomer during handling.
▪ Ensure the inner package is undamaged, the powder is not discolored (yellow or brown), and the liquid is not syrupy. These
conditions indicate the product has not been stored correctly.
▪ Ensure the preparation accessories are specifically compatible with the bone cement product.
▪ Do not open the vial of liquid over the mixing bowl to avoid the risk of glass fragments entering the dough.
▪ Never add other substances or foreign bodies to the acrylic resin. Never modify the ratios between the liquid and solid
components.
▪ Care should be taken in the mixing of the liquid and powder components such that the entire contents of the vial and packet
are utilized. The liquid monomer and the powder component should be thoroughly mixed.
Mixing
1. Always use sterile technique when mixing the bone cement.
2. Open powder packet and break open the vial. Immediately combine the powder and liquid into a mixing bowl or KYPHON™
Mixer.
3. When using the KYPHON™ Mixer, follow the KYPHON™ Mixer instructions for use.
4. When mixing by hand, mix with a spatula until the 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
unmoistened powder into the overall mass of moist dough.
5. After the powder and liquid have been thoroughly mixed, the transfer of the mixture into a cement delivery device(s) may
begin. Allow for complete dissolution of the powder into the liquid prior to transferring the bone cement into the cement
delivery device(s). This can take up to approximately eight minutes after the start of mixing.
Application
When the 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 the bone cement into the fenestrated screw until the bone cement has
reached the doughy state. The cement has reached the doughy state when it no longer sticks to surgical gloves.
1. Before delivery, dispense a small sample of the bone cement from the delivery device to ensure proper viscosity. The bone
cement is not ready to deliver until it does not drip from the cement delivery device, and does not stick to surgical gloves
and has lost its sheen.
2. When the viscosity is correct, the cement can be injected following the screw surgical technique.
3. While the bone cement hardens, it is important to maintain patient positioning until the end of the polymerization or
hardening process.
HOW SUPPLIED
Medtronic HV-R™ Fenestrated Screw 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 resterilize. Do not use if package is open or damaged.
STORAGE
Medtronic HV-R™ Fenestrated Screw Cement should be stored in its original shipping materials. Proper care should be taken to
ensure Medtronic HV-R™ Fenestrated Screw 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
Medtronic HV-R™ Fenestrated Screw Cement.
In no event shall Medtronic be liable for any direct, indirect, incidental, consequential, or exemplary damages arising out of or in
connection with Medtronic HV-R™ Fenestrated Screw Cement, based upon breach of contract (including breach of warranty).
FURTHER INFORMATION
For further information, contact Medtronic.
©2017 Medtronic Sofamor Danek USA, Inc. All rights reserved.
MANUFACTURED FOR:
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
Telephone: 800 933 2635 (USA)
901 396 3133 (outside USA)
Fax: 901 396 0356
EXPLANATION OF SYMBOLS
25°C
Flammable
Sterilized using ethylene oxide (Liquid Package)
Sterilized using aseptic processing techniques (Liquid)
Sterilized using irradiation (Powder)
Batch Code
Catalog number
Do not re-use
Use by
Keep away from sunlight
Store below 25°C
Do not use if package is damaged
For US audiences only
Consult instructions for use at this website.
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