INDICATIONS, SAFETY, AND WARNINGS CD Horizon Fenestrated Screws

IMPORTANT PRODUCT
INFORMATION

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 and lumbar 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 with advanced stage tumors with compromised bone quality.

These implants may also serve as traditional pedicle screws when used without bone cement in patients with non-compromised bone quality.

The 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.

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

To achieve best results, do not use any of the CD HORIZON™ Fenestrated Screw implants with components from any system other than the CD HORIZON™ Spinal System. As with all orthopedic and neurosurgical implants, none of the CD HORIZON™ Fenestrated Screw implants should ever be reused under any circumstances.

INDICATIONS

When used without cement, the 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 (defined 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.

When used in conjunction with Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement, the CD HORIZON™ Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period 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. CD HORIZON™ Fenestrated Screws augmented with either 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, but are not limited to:

• 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 contra-indication to PMMA cement (when used for the cement-related indications).
• Any case where the 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 utilization 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)

• Any case not needing a bone graft and fusion.

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 possible adverse events associated with spinal surgery without instrumentation are possible. With instrumentation, a listing of potential adverse events includes, but is not limited to:

• Early or late loosening of any or all of the components.
• Disassembly, bending, and/or breakage of any or all of the 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 the 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 or 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 the 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, but not limited to, 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

The 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. The safety and effectiveness of this device for any other conditions are unknown. The implants are not prostheses. In the absence of fusion, the instrumentation and/or one or more of its components can be expected to pull out, bend, or fracture as a result of exposure to every day mechanical stresses.

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 utilized, and also with the volume of bone cement used.

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

The safety and effectiveness of this device has not been established for use as part of a growing rod construct. This device is only intended to be used when definitive fusion is being performed at all instrumented levels. The 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

The 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 the implants are important considerations in the successful utilization of the system by the surgeon. Further, the proper selection and compliance of the patient will greatly affect the 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)

The 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 the implants are important considerations in the successful utilization 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.

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.

©2018 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

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IMPORTANT PRODUCT
INFORMATION

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.

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.
• 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.

FURTHER INFORMATION

For further information, contact Medtronic.
©2018 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

IMPORTANT PRODUCT
INFORMATION

IMPORTANT INFORMATION ON THE KYPHON™ XPEDE™ BONE CEMENT

DESCRIPTION

KYPHON™ Xpede™ 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™ Xpede™ Bone Cement. Actual weight percentages of individual components will vary within accepted ranges.

INDICATIONS

KYPHON™ Xpede™ 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 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™ Xpede™ Bone Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period 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. CD HORIZON™ Fenestrated Screws augmented with KYPHON™ Xpede™ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

STERILE

KYPHON™ Xpede™ 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 resterilize. Do not use if package is open or damaged.

CONTRAINDICATIONS

PMMA bone cement is contraindicated in the presence of active or incompletely treated infection at the site where the 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™ Xpede™ Bone Cement is designed and intended for one time use only. Do not re-sterilize and/or reuse. 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; they 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 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. According to the ISO 5833 standard, the temperature can be as high as 90°C ± 5°C.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 surgical 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; 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 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.
• The safety of the bone cement in pregnant women or in children has not been 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 the ratios between the 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 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.
• KYPHON™ Xpede™ Bone 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 KYPHON™ Xpede™ Bone 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 vertebral body without the use of high quality fluoroscopic guidance capable of visualizing movement of bone cement.
• Only physicians thoroughly trained in the surgical use of bone cement and kyphoplasty or vertebroplasty should use KYPHON™ Xpede™ Bone Cement. 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 damaged products. Prior to use, inspect the packaging and product to verify 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.
• 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.

For US Audiences Only

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

FURTHER INFORMATION

For further information, contact Medtronic.
©2018 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