Medtronic 7480724T Instructions for Use

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.