Medtronic VPK1003 Instructions for Use

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.