KYPHON Kurve™ Curved Bone Filler
M708348B495E Rev. A
Device System
2015-09-03
IMPORTANT INFORMATION ON THE KYPHON KURVE™ CURVED BONE FILLER
DEVICE SYSTEM
INDICATIONS FOR USE
The KYPHON V™ Osteo Introducer® System is intended for percutaneous access to bone and the delivery of bone cement,
including during a kyphoplasty or vertebroplasty procedure.
The KYPHON Kurve™ Curved Bone Filler Device is intended for the delivery of bone cement.
The KYPHON® Cement Delivery System is intended for the delivery of bone cement, including during kyphoplasty or
vertebroplasty procedures.
DEVICE DESCRIPTION
Depending on kit configuration, some or all of the devices listed below may be present in the packaging.
KYPHON V™ Osteo Introducer® System Components (Figure 1)
A.
KYPHON V™ Osteo Introducer® Cannula (10g - QTY 1)
B.
KYPHON V™ Osteo Introducer® Stylet (10g - QTY 1)
KYPHON Kurve™ Curved Bone Filler Device (Figure 2)
A. Bone Filler Device Nozzle (QTY 1)
1. Exit Marker
2. Nozzle Position Markers
3. Directional Indicator
B. Bone Filler Device Stylet (QTY 1)
C. Bone Filler Device Plunger (QTY 1)
The position markers on the KYPHON Kurve™ Curved Bone Filler Device Nozzle are used during advancement within the
KYPHON V™ Osteo Introducer® Cannula to indicate the position of the distal tip of the KYPHON Kurve™ Curved Bone Filler
Device with respect to the KYPHON V™ Osteo Introducer® Cannula.
▪ The Exit Marker indicates when the Nozzle is resting against the end of the Cannula.
▪ The 1st Nozzle Position Marker indicates when the Nozzle is angled at approximately 30° beyond the end of the Cannula.
▪ The 2nd Nozzle Position Marker indicates when the Nozzle is angled at approximately 45° beyond the end of the Cannula.
▪ The 3rd Nozzle Position Marker indicates when the Nozzle is angled at approximately 60° beyond the end of the Cannula.
▪ When the Nozzle handle and the Cannula handle are resting against one another, the Nozzle is angled at approximately
90°.
The position marker on the Bone Filler Device Plunger is used during cement delivery to indicate when the distal tip of the
KYPHON Kurve™ Curved Bone Filler Device Plunger is at the beginning of the curve in the KYPHON Kurve™ Curved Bone
Filler Device.
KYPHON® Cement Delivery System (Figure 3 and Figure 4)
A. Gun (QTY 1)
1. Quick Release Button (purple)
2. Lever
3. Tube
4. No-Bleed Connector
B. Cement Cartridges (QTY 2 x 8cc cartridges)
1. Cap
2. Back end
For US Audiences Only
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
WARNINGS
▪ Breakage of KYPHON V™ Osteo Introducer
intervention or retrieval.
▪ Use only the KYPHON V™ Osteo Introducer
with the KYPHON® Cement Delivery System.
▪ Press the (purple) Quick Release Button on the KYPHON
▪ Remove the KYPHON
Curved Bone Filler Device from the patient when not delivering cement to prevent them from becoming fixated within the
vertebral body.
®
Cement Delivery System and the KYPHON V™ Osteo Introducer® Cannula/KYPHON Kurve™
®
System or KYPHON Kurve™ Curved Bone Filler Device may require
®
Cannula or KYPHON Kurve™ Curved Bone Filler Device included in the kit
®
Cement Delivery System Gun to stop cement flow.
PRECAUTIONS
▪ The KYPHON V™ Osteo Introducer
Delivery System are single use devices intended to contact body tissues. Do not reuse, reprocess, or resterilize. Reusing
these devices carries the risk of contamination and may cause patient infection or cross-infection, regardless of the
reprocessing methods. There is also an increased risk of the deterioration of the device performance due to the
reprocessing steps, which may lead to patient injury or death.
®
System, KYPHON Kurve™ Curved Bone Filler Device, and KYPHON® Cement
▪ Reconditioning, refurbishing, repair, modification, or resterilization of the device is expressly prohibited.
▪ It is important to read the Instructions for Use and these precautions carefully prior to device operation.
▪ Use the KYPHON V™ Osteo Introducer
Delivery System prior to the use-by date noted on the packaging.
®
System, KYPHON Kurve™ Curved Bone Filler Device, and KYPHON® Cement
▪ Do not use damaged products. Before use, inspect the components and packaging to verify no damage has occurred.
▪ Do not use this product if you have not been properly trained in its use. Physicians using the devices should be familiar with
the physiology and pathology of the selected anatomy, and be trained in the performance of the surgical technique.
▪ Components of the system should be manipulated only while under fluoroscopic observation with radiographic equipment
that provides high quality images.
▪ Access to the vertebral body via the pedicle requires a minimum pedicle width of 5mm. Insertion of the devices requires
knowledge of the dimensions of the site of insertion to bone as assessed by MRI, CT, or other imaging method.
▪ Never use electric power (or any other alternative power sources) in conjunction with the device. Use only manual power
when using the device.
▪ Use only with Medtronic Polymethyl-Methacrylate (PMMA)-based bone cements. Do not use with bone substitutes or bone
void fillers.
▪ Never deliver bone cement into the vertebral body without the use of fluoroscopic guidance.
▪ Confirm bone cement is delivered to the intended location.
▪ Do not exceed two squeezes of the Gun Lever per second to ensure a smooth, consistent delivery of cement.
▪ Maintain upright position of the Gun during cement fill to ensure proper flow of cement through the system.
▪ Do not attach the Cartridge Cap end of the Cement Cartridge to a Cannula or KYPHON Kurve™ Curved Bone Filler Device
until the cement has reached the intended consistency.
ADVERSE EVENTS
Adverse events potentially associated with use of the device include, but are not limited to:
▪ Nerve injury including puncture of the spinal cord or nerve roots resulting in radiculopathy, paresis, or paralysis.
▪ Embolism of fat, thrombus, or other materials resulting in symptomatic pulmonary embolism or other clinical sequelae.
▪ Hemothorax or pneumothorax.
▪ Deep or superficial wound infection.
▪ Unintended puncture wounds including vascular puncture and dural tear.
▪ Bleeding or hemorrhage.
▪ Hematoma.
▪ Pain.
USE OF KYPHON V™ OSTEO INTRODUCER® SYSTEM (OIS)
1. Make an incision with a scalpel over the access area.
2.
Remove and discard the cap from the KYPHON V™ Osteo Introducer® System.
3.
Using manual control and imaging guidance, advance the KYPHON V™ Osteo Introducer® System with gentle but firm
pressure through the incision to the selected bone surface. Rotate the KYPHON V™ Osteo Introducer® System in
alternating clockwise and counter-clockwise motions for insertion into bone to the intended depth.
NOTE: Markings on the Cannula may be used as reference marks only. They are not intended to replace the use of
fluoroscopic observation.
CAUTION: To maintain structural integrity, do not advance the Cannula without the Stylet fully inserted.
4. While holding the Cannula, rotate the handle counter-clockwise to remove the Stylet. Pull the Stylet straight out from the
Cannula. The Cannula is now in place and ready to accept other devices.
USE OF KYPHON KURVE™ CURVED BONE FILLER DEVICE (BFD)
1.
Place the KYPHON Kurve™ Curved Bone Filler Device with nested stylet into the KYPHON V™ Osteo Introducer® System
Cannula.
NOTE: The distal tip of the KYPHON Kurve™ Curved Bone Filler Device has reached the distal end of the Cannula, or the
working channel, when the Exit Marker on the KYPHON Kurve™ Curved Bone Filler Device enters the proximal end of the
Cannula (i.e., Cannula from KYPHON V™ Osteo Introducer® System).
NOTE: Markings on the Nozzle may be used as reference marks only. They are not intended to replace the use of
fluoroscopic observation.
USE OF KYPHON® CEMENT DELIVERY SYSTEM
1.
Follow the previous Directions For Use for the KYPHON V™ Osteo Introducer® System to create an access channel in the
bone.
2. Follow the Instructions For Use for mixing bone cement (not supplied).
3.
Attach the Cement Cartridge to the KYPHON® Mixer (not supplied) via the luer lock adapter in the cement kit, or if provided,
the dedicated T-Adapter packaged within the KYPHON® Cement Delivery System Cartridge Tray for dual filling of the
Cement Cartridges.
4.
Fill both Cement Cartridges with cement by depressing the plunger on the KYPHON® Mixer until both cartridges are
completely full (16cc total). Fill the Cement Cartridges one at a time with the luer adapter or simultaneously with the TAdapter.
5.
Once filled, remove the Cement Cartridge(s) from the KYPHON® Mixer.
6. Prime the Gun by squeezing the Lever of the Gun slowly and repeatedly until a small amount of sterile water is expelled
from the No-Bleed Connector.
7. Firmly attach the Back End of the Cement Cartridge to the Gun’s No-Bleed Connector.
8. Test the partially assembled system (on the back table) by ejecting a small amount of cement from the Cement Cartridge.
Squeeze the Lever of the Gun until the intended amount and consistency of cement is ejected. This will ensure the cement
flows properly and safely and tests the connections of the system components.
9. For the KYPHON Kurve™ Curved Bone Filler Device, advance the tip to the intended location(s) using imaging guidance.
Verify placement of the tip at the intended prior to the delivery of bone cement. Remove the Stylet from the Nozzle when the
Bone Filler Device is at the intended position.
10. Attach the Cartridge Cap end of the Cement Cartridge to the Cannula or a KYPHON Kurve™ Curved Bone Filler Device.
11. Step away from the operating field to the allowable distance while maintaining a good view of the fluoroscopy monitors.
12. Squeeze the Gun Lever until cement flow is initiated. Monitor under fluoroscopy.
CAUTION: Confirm bone cement is delivered to the intended location.
13. Each full squeeze of the Gun Lever ejects approximately 0.2cc of cement. Dispense slowly and consistently until the
intended cement fill is achieved. Maintain the Gun in the upright position during cement fill at all times.
WARNING: If the flow of cement stops at any time during dispensing, stop dispensing to determine and correct the cause of
the blockage.
NOTE: If cement flows freely from the end of the Cement Cartridge after disconnecting it from a cannula, the blockage is in
the cannula. Correct the cannula blockage or replace the cannula. If cement does not flow freely from the Cement Cartridge
when disconnected from the cannula, the blockage is likely due to improper mixing or air entrapment within the cement mix.
Clear the mix of air to re-establish proper flow, or replace the Cement Cartridge with one properly mixed and filled with
cement.
14. To stop the flow of cement at any time, press the Quick Release Button for 1 second and release. To restart the cement
flow, squeeze the Lever slowly and repeatedly until flow resumes.
15. When the intended amount of cement has been delivered, press the Quick Release Button for 2 seconds to release any
pressure within the dispensing components. This ensures no residual cement remains upon system withdrawal.
16. If additional cement is required, detach the used Cement Cartridge from the No-Bleed Connector of the Gun and replace
with the second pre-filled Cement Cartridge. Firmly re-attach the Cement Cartridge to the No-Bleed connector of the Gun
Tube.
17. Continue with steps 10-15.
18. When finished with cement fill, remove the Cement Cartridge from the Cannula or KYPHON Kurve™ Curved Bone Filler
Device. Tamp down with the OIS Stylet or BFD Plunger, as needed, to expel cement from the KYPHON V™ Osteo
Introducer® System and/or KYPHON Kurve™ Curved Bone Filler Device.
NOTE: Stop BFD Plunger advancement when the position marker on the Plunger enters the proximal end of the handle.
19. Upon completion of procedure, remove the Cannula and/or KYPHON Kurve™ Curved Bone Filler Device from patient.
STERILIZATION
Osteo Introducers, Bone Filler Devices, and Cement Delivery System Guns are sterilized with Gamma irradiation. Cement
Delivery System Cement Cartridge is sterilized by E-Beam irradiation.
STORAGE
The devices should be stored in their original shipping materials. Proper care should be taken to ensure the devices will not be
damaged.
LIMITATION OF LIABILITY
Medtronic will not be responsible for any direct, indirect, incidental, consequential, or exemplary damages resulting from the
reuse of the KYPHON V™ Osteo Introducer® System, KYPHON Kurve™ Curved Bone Filler Device and KYPHON® Cement
Delivery System.
In no event shall Medtronic be liable for any direct, indirect, incidental, consequential, or exemplary damages arising out of or in
connection with the KYPHON V™ Osteo Introducer® System, KYPHON Kurve™ Curved Bone Filler Device and KYPHON
Cement Delivery System based upon breach of contract (including breach of warranty).
®
FURTHER INFORMATION
For further information, contact Medtronic.
©2015 Medtronic Sofamor Danek USA, Inc. All rights reserved.
Figure 1: KYPHON V™ Osteo Introducer® System Components (10g)
Figure 2: KYPHON Kurve™ Curved Bone Filler Device
Figure 3: KYPHON® Cement Delivery System Gun
Figure 4: KYPHON® Cement Delivery System - Cement Cartridges
AUSTRALIAN SPONSOR:
Medtronic Australasia Pty Ltd
97 Waterloo Rd
North Ryde, NSW 2113
Australia
EXPLANATION OF SYMBOLS
Authorized representative in the European Community
The device complies with European Directive MDD
93/42/EEC
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
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
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel: + 31 45 566 80 00
For US audiences only
Sterilized using irradiation
Do not resterilize
Do not use if package is damaged
Use-by date
Consult instructions for use
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