KYPHON ELEMENT™ BONE FILLER
M708348B453E Rev. A
DEVICE
2015-06-11
IMPORTANT INFORMATION ON THE KYPHON ELEMENT™ BONE FILLER DEVICE
INDICATIONS FOR USE
The KYPHON ELEMENT™ Bone Filler Device is intended for the delivery of bone cement, including use during a balloon
kyphoplasty procedure.
DEVICE DESCRIPTION
KYPHON ELEMENT™ Bone Filler Device (Figure 1)
A. Bone Filler Device Nozzle (3)
1. Exit Marker
2. Nozzle Position Markers
B. Bone Filler Device Plunger (3)
1. Plunger Position Markers
▪ The Exit Marker and the 3 position markers (at 1cm increments) on nozzle are used during placement of nozzle tip at
intended location.
▪ The position markers on the plunger are used during advancement of plunger within nozzle. The 3 Plunger Position
Markers are equally spaced from each other.
For US Audiences Only
CAUTION: FEDERAL LAW (USA) RESTRICTS THESE DEVICES TO SALE BY OR ON THE ORDER OF A PHYSICIAN.
WARNINGS
Breakage of the device may require intervention or retrieval.
PRECAUTIONS
The KYPHON ELEMENT™ Bone Filler Device is a single use device intended to contact body tissues. Do not reuse, reprocess,
or resterilize. Reusing this device carries the risk of contamination and may cause patient infection or cross-infection, regardless
of the cleaning and resterilization 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.
▪ It is important to read the Instructions For Use and these precautions carefully prior to device operation.
▪ Use the device prior to the use by date noted on the package.
▪ Do not use if package is opened or damaged because product integrity including sterility may be compromised.
▪ Do not use damaged products. Before use, inspect the device and packaging to verify that no damage has occurred.
▪ Do not use this product if you have not been properly trained in its use. Physicians using the device should be familiar with
the physiology and pathology of the selected anatomy and be trained in the performance of the chosen surgical technique.
▪ The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high
quality images.
▪ Do not re-sterilize and/or reuse. The device is for single use only. Reconditioning, refurbishing, repair, modification, or
resterilization of the device to enable further use is expressly prohibited.
ADVERSE EVENTS
Adverse events potentially associated with use of the device include:
▪ Nerve injury including puncture of the spinal cord or nerve roots potentially 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.
DIRECTIONS FOR USE
1. Remove plunger from the Bone Filler Device Nozzle.
2. Fill the Bone Filler Device Nozzle with bone cement.
3. Remove all air from the nozzle prior to patient use by injection of bone cement to the distal end of the nozzle. The Bone
Filler Device Nozzle accepts up to 1.5 ml of bone cement.
4. Using direct visualization or imaging guidance, advance the nozzle tip through a working channel to the bone void. Verify
placement of nozzle tip at intended location using direct visualization or x-ray imaging prior to delivery of bone cement.
NOTE: The distal tip of the nozzle has reached the distal end of the cannula, or the working channel, when the Exit Marker
on the nozzle enters the proximal end of the cannula (i.e. cannula from KYPHON ELEMENT™ bone access tools).
5. Using imaging guidance, advance the Bone Filler Device Plunger within the nozzle by applying manual pressure to the
plunger handle to deliver bone cement to the intended location. Remove the Bone Filler Device from the working channel.
CAUTION: Do not overfill bone void. Confirm bone cement is delivered to the intended location.
STERILIZATION
Sterilized utilizing irradiation.
HOW SUPPLIED
The KYPHON ELEMENT™ Bone Filler Device is supplied in a sterile form. Packages should be intact upon receipt. Once the
seal on the sterile package has been broken, the product should not be re-sterilized. Damaged packages or products should not
be used, and should be returned to Medtronic.
STORAGE
The devices should be stored in their original shipping materials. Proper care should be taken to ensure that the devices will not
be damaged. Store in a cool dry place.
LIMITATION OF LIABILITY
Medtronic will not be responsible for any direct, indirect, incidental, consequential, or exemplary damages resulting from reuse
of the KYPHON ELEMENT™ Bone Filler Devices.
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 ELEMENT™ Bone Filler Devices, based upon breach of contract (including breach of warranty).
FURTHER INFORMATION
In case of complaint, or for supplementary information, contact Medtronic.
©2015 Medtronic Sofamor Danek USA, Inc. All rights reserved.
Figure 1: KYPHON ELEMENT™ Bone Filler Devices
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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