Medtronic G170059 Technical Manual

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SURGICAL

TECHNIQUE

CD Horizon™ Fenestrated Screw Set with CD Horizon™ Solera™

Voyager™ 5.5/6.0 Systems

TABLE OF CONTENTS

1 Implant Features and Instrument Set

3 Accessing the Pedicle

6 Pedicle Preparation

8 Extender, Cap, and Screw Assembly

9 Screw Insertion

10 Mixing the Cement

13 Using the Cement Delivery Device for Delivery

Step 1: Loading the Cement Delivery Device

Step 2: Checking the Viscosity of the Cement &

Hardening and Working Time Chart

Step 3: Injecting the Cement

17 Removal of the Cement Delivery Guide

18 Measuring the Rod

18 Extenders Alignment

19 Rod Insertion: Percutaneous Technique

23 Rod Insertion: Mini-open Technique

25 Optional Rod Reduction

26 Initial Screw Insertion

28 Additional Compression or Distraction Options

32 Set Screw Final Tightening Insertion

and Break-off

33 Removing Assembly

35 Closure

36 Completing the Procedure

36 Optional Supplemental Procedures

36 Screw Explantation

37 Product Ordering Information

38 Important Information

IMPLANT FEATURES

AND INSTRUMENT SET

CD Horizon™ Fenestrated Screw Set with CD Horizon™ Solera™ Voyager™ 5.5/6.0 Systems offers the same design and capabilities of the CD Horizon™ Solera™ Spinal System Screws, with the addition of six fenestrations near the tip. These features allow cement to pass directly through the screw shaft and fenestrations, providing immediate enhanced fixation in cases with poor bone quality; due to advanced staged tumors.

When used in conjunction with Xpede™ Bone Cement or Kyphon™ HV-R™ 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, lumbar, and sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD Horizon™ Fenestrated Screws augmented with Xpede™ Bone Cement or Kyphon™ HV-R™ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The CD Horizon™ Fenestrated Screw Spinal System may be used without the application of Xpede™ Bone Cement or Kyphon™ HV-R™ Bone Cement and is 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.

Implant

CD Horizon™ Extended Tab Fenestrated Screw

Available for CD Horizon™ 5.5/6.0mm Spinal Systems

5.5/6.0 mm

Cement Delivery Instruments

Cement Delivery Guide Tip, Disposable

Cement Delivery Guide

Cement Delivery Device, Disposable

IMPLANT FEATURES AND INSTRUMENT SET

Cement Mixing

Paddle

Funnel

SyringePlunger

Kyp hon™ Mixer

Kyp hon™ Xpede™ Bone Cement

Kyp hon™ HV-R™ Bone Cement

Multi-tap Adapter

ACCESSING

THE PEDICLE

PAK Needle Insertion

A PAK (Pedicle Access Kit) Needle is used to gain access to the pedicle. After placing the PAK Needle at the intersection of the facet and the transverse process, the needle is advanced in a lateral-to-medial trajectory (Figure 1).

An AP image should show the needle tip at the lateral margin of the pedicle initially. As the needle advances toward the base of the pedicle on the lateral image, it should approach the pedicle center on the AP image (Figures 2a and 2b).

For neuromonitoring, a NIM PAK Needle (Figure 2c) may be used to access the pedicle. Triggered EMG monitoring (Figure 2d) can be performed during advancement of the needle into the pedicle to ensure proper placement.

Important

The PAK Needle should be advanced across the junction of the pedicle and the vertebral body to allow placement of the Guidewire.

The NIM-Eclipse™ Spinal System Surgeon Directed (SD) configuration is intended for use to record, monitor, and stimulate/record biopotential signals including electromyograph (EMG), evoked response and nerve/muscle potentials, and for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction. The system provides feedback to the surgeon and OR team to assist in the localization and assessment of spinal nerves and verification of placement of spinal instrumentation to

avoid injury to at-risk nerveroots.

Please see the NIM-Eclipse™ E4 Spinal System package insert and user’s manual for complete instructions and a list of warnings, precautions, and other medical information.

NIM-Eclipse™ E4 System is manufactured by Medtronic Xomed, Inc. and distributed in the USA by Medtronic Sofamor Danek USA, Inc.

For the complete labeling for the navigation products please contact Medtronic Navigation, General Business at 800-580-8860 or visit www.medtronic.com.

Figure 1

Figure 2a Figure 2b

Figure 2c

Figu re 2d

ACCESSING THE PEDICLE

Guidewire Insertion

The inner stylet of the needle is removed to allow the Guidewire to be inserted into the pedicle (Figures 3a and 3b).

Important

Be extremely careful with regard to the position of the Guidewire. Unintentional advancement of the wire can potentially be very dangerous. Once the Guidewire is inserted, the Cannula may be removed using a rotation technique, leaving only the Guidewire in place. The Guidewire insertion steps should be repeated for each Guidewire that is placed.

Note

Guidewire, Screw Extender placement and rod passage steps are illustrated in this technique on one side only for clarity purposes.

Care should be taken when removing the Cannula to ensure the Guidewire is not also removed. A heavy needle holder may be used to assist with the Cannula removal.

Figure 3a

Figure 3b

ACCESSING THE PEDICLE

Dilating the Fascia

The fascia and muscle must be dilated to allow for screw placement. Place the Tap Sleeve over the Tap and lock it into position by pushing the button (Figure 4). Once it is locked in, there are two stops, one at 10mm and a second stop that allows the Tap to be fully extended. Insert both the Tap and Tap Sleeve into the stab incision over the Guidewire to dilate the fascia and muscle. The Tap Sleeve should be docked on bony anatomy to minimize tissue creep (Figure 5).

Figure 4 Figure 5

PEDICLE

PREPAR ATION

The pedicle is prepared by advancing the Tap along the Guidewire to the desired depth (Figure 6). In dense bone, where the Screw may be difficult to advance, ensure that the pedicle is fully prepared by using a Tap the same size as the Screw to be inserted. Use the SelfDrilling Tap option if particularly hard bone is encountered.

Alternatively, the IPC™ Powerease™ System may be used for tapping (Figure 7). The IPC™ Powerease™ System is a system of powered surgical instruments designed specifically for spine surgery. The IPC™ Powerease™ System Taps and Screwdrivers are cannulated to enable use over a Guidewire. The integrated design allows the Powerease™ Driver to connect directly to the NIM-Eclipse™ System. For comprehensive instructions refer to the Powerease™ User Manual.

Further evaluation of the tapped pedicle can be performed by using the NIM-Eclipse™ System Surgeon directed Ball-Tip Probe (945SPK1004) (Figure 8). Free-running EMG will monitor any nerve root irritation during this procedure (Figure 9).

Figure 6

Figure 7

Note

It is important to keep the Tap along the same axis as the Guidewire. If a change in trajectory is required, the PAK Needle should be reinserted over the Guidewire, the Guidewire removed, and the inner stylet replaced.

Important

Unintentional advancement of the Guidewire should be monitored during this step. To avoid this, ensure the direction of the Tap is in the same plane as the Guidewire. Cleaning the Guidewire prior to tapping can be helpful.

To assemble an instrument with the Powerease™ Driver align the connection end with the Quick Connect on the Powerease™ Driver and insert until the connection end of the instrument is fully seated within the Quick Connect of the Driver (Figures 10a and 10b).

Figure 8 Figure 9

Fully seated Not fully seated

Fig ure 10a Fig ure 10b

Flat transition point

Flat sides should be fully inserted and not be visible.

PEDICLE PREPARATION

Screw length can be estimated by referencing the depth marks on the Tap with the rim of the Tap Sleeve (Figure 11). To ensure accuracy, the Tap Sleeve must be docked on bone.

Fluoroscopy should be used to verify the position of the Guidewire and the Tap during this step, After tapping, remove the Dilator but leave the Guidewire in place.

Helpful Information

If you tap beyond the tip of the Guidewire, bone within the end of the Tap may cause the Guidewire to pull out as you remove the Tap. To avoid this, advance the Guidewire through the Tap before you remove the Tap from the vertebral body. If the Guidewire becomes bent, place a PAK Cannula over the bent Guidewire, then replace it with a new Guidewire.

Important

Care should be taken when removing the Tap Sleeve and Tap not to inadvertently remove the Guidewire.

Fi gur e 11

EXTENDER, CAP, AND

SCRE W ASSEMBLY

Before a Screw can be inserted into the pedicle, the Tab Extenders and Cap (Figure 12a) must be assembled with the Extended Tab Fenestrated MultiAxial Screws. To assemble the Screw Extenders, insert the Extended Tab Fenestrated Multi-Axial Screw Head into the Tab Extenders until locked with an audible click and tactile feedback. With both Tab Extenders locked onto the Extended Tab Multi-Axial Screw Head, insert the Cap into the forked tips of the Tab Extenders (Figure 12b).

Note

To ensure Cap is locked onto Tab Extenders, listen for an audible click.

Figure 12a

Figure 12b

SCREW

INSERTION

Insert the Cannulated Retaining Bonescrew Driver into the Screw Extender Assembly. The tip of the driver passes into the head of the Screw until the driver fully engages the Screw (Figure 13).

Thread the Sleeve of the Retaining Driver into the head of the Screw before inserting over the Guidewire (Figure 14).

The entire Screw Extender Assembly is inserted over the Guidewire and into the pedicle (Figure 15). If the Screw is difficult to advance, remove the assembly while leaving the Guidewire in place, and ensure the pedicle is fully prepared by using a Tap the same diameter as the inserted Screw. After driving the Screw Assembly through the pedicle, remove the Guidewire to prevent it from being advanced. Be certain that the Screw Assembly is not inserted too far. If the multi-axial head of the CD Horizon™ Fenestrated Extended Tab MultiAxial Screw is driven too forcefully against the bone, it will lose its multi-axial capabilities, making it difficult to connect the assemblies during subsequent steps.

Figure 13

Fig ure 14

Note

The IPC™ Powerease™ System may be used for insertion of CD Horizon™ Fenestrated Extended Tab 5.5/6.0mm System Screws. The IPC™ Powerease™ System is a system of powered surgical instruments designed specifically for use in spine surgery. The Powerease™ System Taps and Screwdrivers are cannulated to enable use over a Guidewire. These Taps and Screwdrivers can be used manually or with the IPC™ Powerease™ System. For comprehensive instructions refer to the Powerease™ User Manual.

The process is repeated for additional Screws on the same side. After inserting the assemblies, the Screw Extenders should be at approximately the same height outside the patient. The assemblies should move freely following Screw insertion. Unthread and remove the driver (Figure 16).

Figure 15

Figure 16

MIXING

THE CEMENT

To prepare both the Xpede™ and HV-R™ Cement, insert the funnel into the Kyphon™ Mixer. Make sure the purple valve levers are facing up so they are in the closed position (Figure 17).

Closed position

For both the Xpede™ and HV-R™ Cements:



Pour the entire contents of the Cement powder packet into the Kyphon™ Mixer (Figure 18). Remove the funnel from the mixer.

Fi gur e 17

Figu re 18

MIXING THE CEMENT

For both the Xpede™ and HV-R™ Cements:



Take the syringe and blunt needle and thread together. Snap off the bottle cap of the Cement liquid and use the syringe and needle assembly to extract the contents (Figures 19a and 19b).

Figure 19a

For both the Xpede™ and HV-R™ Cements:



Inject the liquid into the Kyphon™ Mixer (Figure 20).

Figure 19b

Figure 20

MIXING THE CEMENT

Below times are based on testing in a 23° C (73° F) setting.

For HV-R™:

2 min.



Insert the paddle (Figure 21a).



Hold the Kyphon™ Mixer at the base and mix

For Xpede™:

30 sec.

the cement for approximately two minutes when using HV-R™ and 30 seconds for Xpede™ Cements by agitating the paddle (Figure 21b).

Note

The mixing and curing characteristics of the cement will vary according to type of cement used (Xpede™ vs HV-R™ Cements), temperature and other factors. For example, in cooler environments it may be desired to mix for slightly longer to achieve a more viscous consistency before filling the Cement Delivery Devices. Refer to the appropriate Cement instructions for use.

Base must be kept stable

Fig ure 21a Fig ure 21b



Remove the paddle and insert the plunger (Figure 22).

Important

The Cement Delivery Device should be loaded immediately once the cement is mixed.

Figure 22

USING THE CEMENT DELIVERY

DEVICE FOR DELIVERY

STEP 1:

Loading the Cement Delivery Device

There are two methods for Loading the Cement Delivery Device:



Multi-tap Adapter: The Kyphon™ Multi-tap Adapter is used to fill six Cement Delivery Devices with Xpede™ or HV-R™ Cement. Attach the six Cement Delivery Devices to the Multi-tap Adapter and attach the assembly to the Kyphon™ Mixer (Figure 23a). Lower both valve levers and fill the Cement Delivery Devices by pressing down on the plunger (Figure 23b).



Individual Cement Delivery Devices: Alternatively, when using HV-R™ Cement, individual Cement Delivery Devices can be sequentially attached to the Kyphon™ mixer by threading it onto the Luer Lock at the base of the mixer.

Important

The Multi-tap Adapter must be used when using Xpede™ Cement. The handling period for Xpede™ Cement does not allow for multiple Cement Delivery Devices to be loaded individually.

Note

Each Cement Delivery Device distributes 1.8cc of cement. Do not use Kyphon™ Bone Filler Device as it is not compatible with the CD Horizon™ Extended Tab Fenestrated Screw

Figure 23bFigure 23a

Clockwise screwing action

Unlocked valve levers

USING THE CEMENT DELIVERY DEVICE FOR DELIVERY

STEP 2:

Checking the Viscosity of the Cement

Below times are based on testing in a 23° C (73° F) setting.

For HV-R™:

8.5 min.

For Xpede™:

2 min.

Begin checking the viscosity of the cement after approximately 8.5 minutes (HV-R™ Cement) and 2 minutes (Xpede™ Cement). To check the viscosity, eject a small amount from the tip of a filled Cement Delivery Device.

Lightly pinch the cement between gloved fingers. If fiber tendrils are seen and the cement is sticky, it is not ready and should be allowed to stand further. The cement has become doughy and is ready for application when the gloved finger separates cleanly and the cement has lost its sheen (Figure 24).

Note

Do not roll between finger tips; use a pinching motion.

Time should be measured beginning with initial mixing of the cement, not from the loading of the Cement Delivery Device.

The time for the cement to harden will vary according to the type of cement used (Xpede™ Cement vs HV-R™ Cement) and the temperature of the OR. Below are the average Hardening Times when Xpede™ and HV-R™ Cements are used with the size 3 Cement Delivery Device at 23° C (73° F). For additional average times refer to the cement instructions for use.

Cement is NOT REA DY

Cement is READY

Figure 24

Hardening Time (time begins when cement is first mixed)

Working Time (Hardening time – time to doughy s tate)

HV-R™ Cemenrt with Size 3 Cement Delivery Device

19.3 minutes

10.4 minutes (19.3- 8.9 minutes)

USING THE CEMENT DELIVERY DEVICE FOR DELIVERY

STEP 3:

Injecting the Cement

For both the Xpede™ and HV-R™ Cements:



Press the disposable Cement Delivery Guide tip into the distal tip of the cement delivery guide (Figures 25a and 25b).



Place the distal tip through the cap of the screw and thread the Cement Delivery Guide into the screw head (Figure 25c).

Note

When the Cement Delivery Guide is full seated, laser markings on the Cement Delivery Guide are just below the markings on the extenders (Figure 25d).

Figure 25a Figure 25b Figure 25c Figure 25d

USING THE CEMENT DELIVERY DEVICE FOR DELIVERY



Insert the Cement Delivery Device into the cannula of the Cement Delivery Guide until the wings of the Cement Delivery Device snaps into the neck of the Cement Delivery Guide and an audible click is heard.



Insert the plunger portion of the Cement Delivery Device

into the outer sheath (Figure 26) and inject the cement by depressing the plunger until the desired volume of cement is delivered (Figure 27).

Figure 26



Repeat injection for each Screw. Once the cement is set, see page 17 for steps to remove

Figure 27

the Cement Delivery Guide and steps to complete

Note

the procedure.

One Cement Delivery Device can dispense 1.8cc of cement. See markings on the plunger that indicate every 0.4cc of cement.

Important



Cement injection should only be performed under fluoroscopic control.



Remove the Cement Delivery Guide at approximately 3 minutes post-cement injection to avoid pulling cement into the saddle of the screw.



Remove the Cement Delivery Device from the Cement Delivery Guide post-cement injection.



Recommended volumes per pedicle for T1-T10 are

0.8cc and for T11-L5 are 1.8cc.

REMOVAL OF THE

CEMENT DELIVERY GUIDE

Disengaging the Cement Delivery Guide from the Fenestrated Extended Tab Screw

For both the Xpede™ and HV-R™ Cements:



At approximately 3 minutes post-cement

injection, unthread the Cement Delivery Guide in a counterclockwise direction (Figures 28a and 28b).

Figure 28bFigure 28a

MEASURING

THE ROD

To determine the appropriate Rod length, place the Rod Template into the cephalad and caudal Screw Extenders. The Rod Template Scale reads the minimum Rod length required (Figure 29).

Note

The Rod Template should be fully seated in the Screw Extender Assemblies to obtain an accurate reading. Make sure that the top of the Extender Cap is aligned with the ledge on the Rod Template.

EXTENDERS

ALIGNMENT

Begin the Rod insertion step by rotating the Tab Extenders, as needed, until the Rod slots are aligned for Rod passage (Figure 30).

Figure 29

Figure 30

ROD INSERTION:

PERCUTANEOUS TECHNIQUE

To attach the Rod to the Percutaneous Rod Inserter, press the button behind the clasp to open the secondary lock stage (Figure 31a). Next, lift the clasp further to open the primary lock stage (Figure 31b). Insert the appropriate length Rod with the Medtronic part number on the Rod facing right. Press the clasp closed until it clicks to lock the Rod in the Inserter.

If needed, use the Rod Bender to bend the Rod according to patient anatomy (Figure 31c). Do not bend the Rod prior to placing it in the Percutaneous Rod Inserter. To estimate any bend for the Rod, place the Percutaneous Rod Inserter lateral to the patient and take a lateral fluoroscopy. Next, compare the bend in the Rod-toScrew trajectory and alter as needed.

Note

Capped Rods cannot be used for this Rod insertion method.

When the clasp is open, a T25 Driver may be used to adjust the tension of the Inserter’s locking mechanism, if needed.

Do not adjust the tension while clamping a rod.

Figu re 31a

Figu re 31c

Figu re 31b

ROD INSERTION: PERCUTANEOUS TECHNIQUE

Rod Passage Through First Extender — Cephalad to Caudal

With the Rod securely attached to the Percutaneous Rod Inserter, pass the Rod through the same incision as the most cephalad Extender. The Rod will enter through the Extender Rod Channel by inserting the Rod at an angle inclined relative to the Extender (Figure 32). Use AP and lateral fluoroscopy as necessary in combination with tactile and visual feedback to find the path through the remaining Extenders.

Important

It is very important to pass the Rod cephalad to caudal to allow laminar shingling to serve as an additional safety measure for protecting the spinal canal.

Note

If needed, appropriately extend the incision to ensure that the Rod can be completely seated.

Figure 32

ROD INSERTION: PERCUTANEOUS TECHNIQUE

Rod Passage

After the Rod is through the first Extender, guide it via the steering handle of the Rod Inserter through the remaining Extenders using tactile feel, and AP and lateral fluoroscopy, as necessary. The Rod Inserter is designed so it cannot pass through the first Extender. The Rod Inserter Tip should be inserted until it is against the cephalad Screw Extender (Figure 33a). A sliver of Rod should be visible from the most caudal Screw of the construct on fluoroscopy (Figure 33b).

Note

During Rod passage, the Rod should be below the fascia at all levels. The lordosis in the Rod may allow the Rod to sit proud above the fascia distally, and if this is not recognized the Rod may not reduce into the Screw.

Figu re 33bFigu re 33a

ROD INSERTION: PERCUTANEOUS TECHNIQUE

Rod Verification

Once the Rod is passed through the Rod Channels of the Extenders, additional methods may be used to verify Rod passage such as rotating each of the Extenders by hand. If the Extenders rotate freely, then the Rod has not passed through the Extenders.

The Ball-Ended Driver or the Non-Retaining Driver may also be used to confirm Rod passage by placing the Driver into each Extender. The Rod has passed correctly into the Screw Head if the laser marked line on the Driver is visible above the Extender Cap (Figure 34).

With the Rod confirmed through all of the Extenders, lateral fluoroscopy may be used to ensure there is Rod overhang from the most cephalad and caudal Extenders (Figure 35).

Figure 34

Figu re 35

ROD INSERTION:

MINI-OPEN TECHNIQUE

If the Mini-Open Rod Insertion Technique is chosen, the fascia between the Screw Extenders must be incised if it has not already been done. Start by dissecting the soft tissue and muscle between the Screw Extender Assemblies to create a channel for the placement of the Rod. With this insertion method, it is recommended that the Capped Rod be used.

Press the button behind the clasp to open the secondary lock stage. Next, lift the clasp further to open the primary lock stage (Figure 36a). Load the appropriate size Rod as determined by the Rod Template into the Rod Gripper. Press the clasp closed until it clicks to lock the Rod in the Rod Gripper (Figure 36b).

Up to Open

Open and Load

Note

Pull on the Rod to ensure the Rod is securely attached to the Rod Gripper.

For single-level constructs, place the Rod Gripper in the middle of the Rod. For multilevel constructs, place the Rod Gripper near the caudal end leaving about 15 – 20mm of Rod visible.

When the clasp is open, a T25 Driver may be used to adjust the tension of the Inserter‘s locking mechanism, if needed.

Figure 36a

Down to Secure

Close and Secure

Figure 36b

ROD INSERTION: MINI-OPEN TECHNIQUE

Pass the Rod into the openings on the top of the Tab Extenders (Figure 37a). Align Rod so the End Caps of the Rod extend to both sides of the Tab Extenders (Figure 37b). Push Rod down to fully seat in the Screw Heads (Figure 37c). Rod confirmation can be made using fluoroscopy (Figure 38).

Helpful Hint

Measure segmental lordosis either at the operative level to confirm maintenance or restoration relative to baseline measurements manually or by leveraging a mobile-device based measurement application.

Figu re 37a

Fig ure 37b Fi gur e 37c Figure 38

OPTIONAL ROD

REDUCTION

If needed the Rod Reducers (Figure 39) may be used to sequentially reduce the Rod into the Screw Heads. Make sure the marked line in the window lines up with LD by unscrewing the top portion of the Rod Reducer. Remove the Cap from the Extender and slide the Reducer over the Extenders. The Extender Tabs should be visible in the lower window on the Rod Reducer (Figure 40a).

Once the Rod Reducers are in position, sequentially tighten them until the the marked line in the window lines up with RD. The Nut Driver and Quick Connect Ratcheting Egg Handle may be attached to the top of the Rod Reducer to more easily reduce the Rod. RD indicates that the Rod is fully reduced into the Screw Head (Figure 40b).

Note

The line visible in the window during reduction indicates how close the Rod is to being

fullyreduced.

Figure 39

Figure 40a Figure 40b

INITIAL SET SCREW

INSERTION

After verifying that the Rod is seated in all the Screws, the Set Screws can be inserted with the Set Screw Retaining Driver. Begin by loading the Set Screw on the tip of the Set Screw Retaining Driver. Push the button of the Set Screw Retaining Driver Handle (Figure 41). While pushing the button, insert the Set Screw on the distal tip of the Set Screw Retaining Driver (Figure 42). Release the button and tug on the Set Screw to ensure a secure connection.

Note

The button on the Set Screw Retaining Driver Handle should be proud once the Set Screw is loaded.

Figu re 41

Figure 42

INITIAL SET SCREW INSERTION

Provisionally tighten the Set Screws by inserting the Set Screw Assembly down the Tab Extenders (Figure 43). If the black line on the Set Screw Retaining Driver is visible, the Rod is not fully seated (Figure 44).

Provisionally tighten all Set Screws to secure the Rod.

Figure 43 Figure 44

ADDITIONAL COMPRESSION

OR DISTRACTION OPTIONS

CD Horizon™ Fenestrated Screw Set with CD Horizon™ Solera™ Voyager™ 5.5/6.0 Systems offer multiple compression and distraction options.

Compression/Distraction with the Fulcrum

The first option for compression and distraction is the Fulcrum Method. To use the Fulcrum Method, first remove the Caps from the Screw Assembly. Next, place the Reinforcement Sleeve over the Extender, taking care to ensure that the Reinforcement Sleeve is fully seated on the Extenders (Figure 45). The extender tips will be visible in the windows. Lock the Reinforcement Sleeve into place by placing downward pressure on the top of the Reinforcement Sleeve. When the Reinforcement Sleeve locks, there is an audible click. To ensure that the Reinforcement Sleeve is locked gently pull up on the middle of the Reinforcement Sleeve. Repeat the placement of the Reinforcement Sleeve on the second Screw Assembly.

Note

When the cap is removed the screw extender tabs are vulnerable to tab break off; minimal medial-lateral forces should be placed on the tab extenders prior to attaching the reinforcement sleeve.

After placing the Reinforcement Sleeves, place the Fulcrum on top of the Reinforcement Sleeves. The Fulcrum must be placed past the locking cap of the Reinforcement Sleeve and above the flat portion of the Reinforcement Sleeve (Figure 46). Loosen the Set Screws on the Screw Assemblies you wish to be mobile. To adjust the Fulcrum, unscrew the back thumbscrew and slide the rack body so that it will slide over the Screw Extenders with the Reinforcement Sleeves. Lock the Fulcrum in place by tightening the back thumbscrew. To distract, position

the Fulcrum Pliers above the Fulcrum. Tocompress,

position the Fulcrum Pliers below the Fulcrum. Once the Fulcrum Pliers are positioned, squeeze the pliers to compress or distract (Figure 47). Once the surgeon has compressed or distracted the desired amount, insert and provisionally re-tighten the Set Screws to hold the achieved correction. Remove the Fulcrum and the Reinforcement Sleeves.

Figure 45 Figure 46 Fig ure 47

ADDITIONAL COMPRESSION OR DISTRACTION OPTIONS

Compression with the Pliers

The second option for achieving compression is to use the Pliers Compressor. The Caps do not have to be removed to use the Pliers Compressor. Slide the compressor instrument along the outside of the Extenders and down to the Rod of the Screws to be compressed (Figure 48). Loosen the Set Screws on the Screw Assemblies you wish to be mobile. Perform the compression and then tighten the Set Screws to maintain the compression (Figure 49).

Figure 49Figure 4 8

ADDITIONAL COMPRESSION OR DISTRACTION OPTIONS

Compression/Distraction with the Rack

The third option for compression and distraction is the Rack Compressor/Distractor. It is only available in the long rod instrument set. To use the Rack Compressor/Distractor, place the Reinforcement Sleeves on the Screw Assembly as previously described. Next, place the Rack on the Reinforcement Sleeves taking care to ensure that it is positioned below the locking cap of the Reinforcement Sleeve (Figure 50). Loosen the Set Screws on the Screw Assemblies you wish to be mobile. Twist the knob on the Rack to compress or distract. The Quick Connect Ratcheting Egg Handle may be attached to the end of the Rack for ease of use (Figure 51). Once the surgeon has compressed or distracted the desired amount, provisionally re-tighten the Set Screws to hold the compression or distraction and then remove the Rack Compressor/Distractor and the Reinforcement Sleeves.

Figure 50 Fig ure 51

ADDITIONAL COMPRESSION OR DISTRACTION OPTIONS

Compression/Distractor with the A/B Compressor Arms

Begin by loosening the Set Screw from the Screw in the vertebral body that needs to be adjusted.

To use the A/B Compressor/Distractor Arms remove the Caps from the Tab Extenders (Figure 52). Compressor/ Distractor Arms should be assembled with Tab Extenders one arm at a time and then locked together. Align Compressor/Distractor Arm A over the Tab Extender and slide down until contact is made with Rod (Figure 53). If the black line on the Tab Extender is visible through the Compressor/Distractor Arm window, the Compressor/Distractor Arm is fully seated (Figure 54). Next, align Compressor/Distractor Arm B over the Tab Extender and slide down until contact is made with the Rod. At this point the two arms should lock together.

To compress, squeeze the two arms together (Figure 55). To distract, pull the two arms apart (Figure 56).

Note

Compressor Arm A should always be placed first, with the noted opening facing the opposing Screw. (The Screw that Compressor Arm B will be placed on).

The A/B Compressor is not in the set configuration and must be ordered separately.

Figu re 52 Figu re 53

Compressor/ Distractor Arm A

Compressor/ Distractor Arm B

Figure 56Figure 55Figure 54

SET SCREW FINAL TIGHTENING

INSERTION AND BREAK-OFF

Once the Rod has been reduced and/or compression or distraction has been achieved and all implants are securely in place, final tightening may be performed. It is preferred that compression be released just prior to the Set Screws being broken off or final tightening. This technique will help ensure that the Implant Head and Rod are normalized to one another and allow for the Rod to be fully seated in the Implant Head during the final tightening step. Once these maneuvers are performed, the Set Screws should be broken off.

If the Rod Reducer is being used, position the Rod Reducer Counter Torque around the Rod Reducer (Figure 57). Insert the Set Screw Driver into the Rod Reducer and ensure it is fully engaged with the Set Screw by gently pulling upward. The Break-Off Handle should be attached to the Set Screw Driver to facilitate the final break-off of the Set Screw. Tighten Set Screw to break-off. Once the Set Screws are broken off the Rod Reducer can be removed from the Extender Assembly by unlocking it.

The Ring Counter Torque is used with the Extenders and Caps for final tightening. Slide the Ring Counter Torque over the Extenders (Figure 58) and position the bottom portion around the Screw Head and the top portion around the Cap (Figure 59). The Break-Off Handle should be attached to the Set Screw Driver to facilitate the final break-off of the Set Screw. Tighten Set Screw to breakoff. Once the Set Screw is broken off the Ring Counter Torque can be removed.

Note

Do not push the button on the top of the Set Screw Retaining Driver Handle until it is completely removed from the Extender as this will release the Set Screw Retaining Driver Handle while pushing in the button on the top of the handle to reconnect the Set Screw.

Figure 57 Figure 58 Figure 59

REMOVING

ASSEMBLY

To break-off the Extender Tabs, slide the Tab Breaker over each of the Tab Extenders. Ensure that the button slides upward to engage the Extender. Apply downward pressure to the Tab Breaker while simultaneously moving it medial-to-lateral (Figure 60). The tabs will break-off and be retained in the Tab Breaker along with the Extender. Flip the Tab Breaker and repeat on the second Extender.

Once the Tab Breaker is removed from the surgical site, remove the Tab Extender from the Tab Breaker by sliding the button down and the Extender will slide out.

To remove and dispose of the Break-Off Tab from the Tab Extender, use the Break-Off Removal Tool (Figure 61).

Note

Once the break-off portion of the Screw is removed from the Tab Extender, “screw portion” must be discarded.

PlaceTab Extender back in loaner kit so that it can be used for futuresurgeries.

Figure 6 0

Fig ure 61

REMOVING ASSEMBLY

To remove the Tab Extenders from an unused Tab Extender Screw Assembly, use the side portion of the Break-Off Removal Tool (Figure 62).

Figure 62

Note

The Tab Removal Tool may also be used to remove the break-off portion of the Set Screw if needed from the Set Screw Driver after final tightening. Place the break-off portion of the Set Screw in the slot as illustrated below and pull up on the Set Screw Driver while pressing on the top handle to release the break-off portion of the Set Screw (Figure 63).

Figure 63

CLOSURE

The entire process is repeated on the contralateral side. Closure is accomplished with a few interrupted stitches in the fascia, a subcuticular skin structure, and Steri-Strips™ (Figure 64).

Figure 6 4

COMPLETING

SCREW

THE PROCEDURE

See the appropriate CD Horizon™ Solera™ Voyager™ Spinal System SurgicalTechniquefor guidance in rod, set screw and transverse link placement, final tightening, and bone grafting.

OPTIONAL

SUPPLEMENTAL PROCEDURES

A corpectomy procedure may be used as a supplemental procedure to a fenestrated screw construct as deemed necessary by a physician. The CD Horizon™ Extended Tab Fenestrated Screws may be used with any Medtronic corpectomy device cleared for use in the thoracic, lumbar, and sacral spine and is indicated for a tumor pathology. Refer to the appropriate surgical technique and package insert for guidance, indications, contraindications, and warnings for cleared Medtronic corpectomy devices.

Kyp hon™ Balloon Kyphoplasty or Vertebroplasty is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer or benign lesion.

The OsteoCool™ RF Ablation System is intended for ablation of benign bone tumors such as osteoid osteoma and for the palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body. It is also intended for coagulation and ablation of tissue in bone during surgical procedures, including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.

EXPLANTATION

If removal of a Fenestrated Screw is necessary, attach a standard Medtronic Quick Connect Handle to the T25 screwdriver.

Next, fully engage the T25 end of the driver into the screw head; then thread the instrument sleeve into the screw head. Turn counterclockwise until the Fenestrated Screw is removed.

Note

For both the Xpede™ and HV-R™ Cements: The cured cement will break away from the screw under this torsional force to allow for screw removal.

TUMOR

INDICATION

CD Horizon™ Fenestrated Screw Set with CD Horizon™ Solera™ Voyager™ 5.5/6.0 Systems provide immediate enhanced fixation in poor bone quality due to advance stage tumors through the application of Xpede™ Bone Cement or Kyphon™ HV-R™ Bone Cement.

TRAUMA

INDICATION

When used for trauma (fracture/dislocation) without cement augmentation, this construct serves as an adjunct to fusion holding the bones together until they heal with the usage of graft material left to the surgeon’s discretion.

PRODUCT ORDERING

INFORMATION

Fenestrated Extended Tab MAS Non-Sterile Implant Set SPS03020

CFN Description Qty

55850024530 4.5mm × 30mm 6

55850024535 4.5mm × 35mm 6

55850024540 4.5mm × 40mm 6

55850024545 4.5mm × 45mm 4

55850025530 5.5mm × 30mm 6

55850025535 5.5mm × 35mm 8

55850025540 5.5mm × 40mm 12

55850025545 5.5mm × 45mm 12

55850025550 5.5mm × 50mm 8

55850026530 6.5mm × 30mm 2

55850026535 6.5mm × 35mm 6

55850026540 6.5mm × 40mm 12

55850026545 6.5mm × 45mm 12

55850026550 6.5mm × 50mm 12

55850026555 6.5mm × 55mm 4

55850027535 7.5mm × 35mm 4

55850027540 7.5mm × 40mm 6

55850027545 7.5mm × 45mm 6

55850027550 7.5mm × 50mm 6

55850027555 7.5mm × 55mm 2

6553004 Extended Tab FNS MAS Implant Tray 1

1850097 Lid, Generic Base 1

FNS Voyager™ MAS Instrument Set SPS03023

Part Number Description Qty

6550041 Cement Delivery Guide 10 5584007 Screw Conrmation Tool 1 6551004 4.5mm One-Step Tap 1 6551005 5.5mm One-Step Tap 1 6551006 6.5mm One-Step Tap 1 6551007 7.5mm One-Step Tap 1

6551045 4.5-5.5mm One-Step Drill Tap 1

6551056 5.5-6.5mm One-Step Drill Tap 1

6550000 Tap Sleeve 1 6550017 5.5/6.0 Tab Extender 12 6550016 5.5/6.0 CAP 6 6553000 5.5/6.0 FNS Extended TAB MAS Instruments 1 6553005 Extended Tab FNS Caps / Extenders Caddy 1 1850097 Caddy Lid, , Generic Base 1

CD Horizon™ Solera™ Voyager™ 5.5/6.0mm Capped Rods and Instruments Set Type SPS02889

Part Number Description Qty

6550014 Rod Gripper 1

651003030 5.5mm Cobalt Chrome Capped Rod, 30mm 3

651003035 5.5mm Cobalt Chrome Capped Rod, 35mm 3

651003040 5.5mm Cobalt Chrome Capped Rod, 40mm 3

651003045 5.5mm Cobalt Chrome Capped Rod, 45mm 3

651003050 5.5mm Cobalt Chrome Capped Rod, 50mm 3

651003055 5.5mm Cobalt Chrome Capped Rod, 55mm 3

651003060 5.5mm Cobalt Chrome Capped Rod, 60mm 3

651003065 5.5mm Cobalt Chrome Capped Rod, 65mm 3

651003070 5.5mm Cobalt Chrome Capped Rod, 70mm 3

651003075 5.5mm Cobalt Chrome Capped Rod, 75mm 3

651003080 5.5mm Cobalt Chrome Capped Rod, 80mm 3

CD Horizon™ Solera™ Voyager™ 5.5/6.0mm Percutaneous Rods and Instruments and Instrument Set Set Type SPS02890

Part Number Description Qty

651000030 5.5mm Cobalt Chrome Percutaneous Rod, 30mm 4

651000035 5.5mm Cobalt Chrome Percutaneous Rod, 35mm 4

651000040 5.5mm Cobalt Chrome Percutaneous Rod, 40mm 4

651000045 5.5mm Cobalt Chrome Percutaneous Rod, 45mm 4

651000050 5.5mm Cobalt Chrome Percutaneous Rod, 50mm 4

651000055 5.5mm Cobalt Chrome Percutaneous Rod, 55mm 4

651000060 5.5mm Cobalt Chrome Percutaneous Rod, 60mm 4

651000065 5.5mm Cobalt Chrome Percutaneous Rod, 65mm 4

651000070 5.5mm Cobalt Chrome Percutaneous Rod, 70mm 4

651000075 5.5mm Cobalt Chrome Percutaneous Rod, 75mm 4

651000080 5.5mm Cobalt Chrome Percutaneous Rod, 80mm 4

651000085 5.5mm Cobalt Chrome Percutaneous Rod, 85mm 4

651000090 5.5mm Cobalt Chrome Percutaneous Rod, 90mm 4

CD Horizon™ Solera™ Voyager™ 5.5/6.0mm Universal Instruments Set Type SPS02894

Set 6 - Fenestrated Extended Tab Cement Delivery Device Disposable Kits SPS03026

Part Number Description Qty

A07A Kyphon™ Mixer 1 6550102 Cement Delivery Device (Box of 2) 4

6550202 Cement Delivery Guide TiP, 2-Pack 5

A23 Kyphon™ Multi-Tap Adapter 1

Part Number Description Qty

6550027 5.5/6.0mm Rod Reducer 2

6550031 5.5/6.0mm Nut Driver 2

6550009 5.5/6.0mm Plier Compressor 1

6550034 5.5/6.0mm Reinforcement Sleeve 2

6550035 5.5/6.0mm Fulcrum Pliers 1

6550036 5.5/6.0mm Fulcrum 1

7480162 French Bender 1

PRODUCT ORDERING INFORMATION

CD Horizon™ Solera™ Voyager™ 5.5/6.0mm Longer Percutaneous Rods Set Type SPS02892

Part Number Description Qty

654000100 5.5mm Titanium Percutaneous Rod, 100mm 3

654000110 5.5mm Titanium Percutaneous Rod, 110mm 3

654000120 5.5mm Titanium Percutaneous Rod, 120mm 3

654000130 5.5mm Titanium Percutaneous Rod, 130mm 3

654000140 5.5mm Titanium Percutaneous Rod, 140mm 3

654000150 5.5mm Titanium Percutaneous Rod, 150mm 3

654000160 5.5mm Titanium Percutaneous Rod, 160mm 3

654000170 5.5mm Titanium Percutaneous Rod, 170mm 3

654000180 5.5mm Titanium Percutaneous Rod, 180mm 3

654000190 5.5mm Titanium Percutaneous Rod, 190mm 3

654000200 5.5mm Titanium Percutaneous Rod, 200mm 3

6550027 5.5/6.0mm Rod Reducer 4

6550011 5.5/6.0mm Rack Distractor/Compressor 2

6550034 5.5/6.0mm Reinforcement Sleeve 2

6550017 5.5/6.0 Tab Extender 18

6550016 5.5/6.0 CAP 10

CD Horizon™ Solera™ Voyager™ 5.5/6.0mm Universal Instruments Set Type SPS02888

Part Number Description Qty

8670001 Guidewire, Blunt 6

8670002 Guidewire, Sharp 6

7579000 Quick Connect Ratcheting T-Handle 1

G170059 Ratcheting Handle 2

6550016 5.5/6.0 Cap 10

6550017 5.5/6.0 Tab Extender 18

6550002 5.5/6.0 MAS Driver 2

6550003 5.5/6.0 Non-Retaining Driver T27 1

7480147 T27 Driver, Quick Connect 1

6550004 Ball-Ended Driver 1

6550013 Rod Template 5.5 1

9010000849 Percutaneous Rod Inserter 2

6540530 5.5/6.0mm Break-O Set Screw 20

6550006 5.5/6.0mm Set Screw Driver 2

6550022 5.5/6.0mm Ring Counter Torque 1

6550021 5.5/6.0mm Reducer Counter Torque 1

6550020 5.5/6.0mm Tab Removal Tool 1

6550019 5.5/6.0mm Tab Breaker Removable 2

7570090 Break-O T-Handle 1

8350312 Rod Holder 1

IMPORTANT PRODUCT

INFORMATION

Important Information on the CD Horizon™ Fenestrated Screw Set

URPOSE

The CD Horizon™ Fenestrated Screw Set is intended to help provide immobilization and stab ilizatio n of spinal se gments o f the thora cic, lum bar, or sacral s pine.

DESCRIPTION

The CD Horizon™ Fenest rated Screw S et consist s of a variet y of cannul ated screws . These screws contain a series of fenestrations which allows polymethylmethacrylate (PMMA) bone cement (Kyphon™ HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, or Medtronic HV-R™ Fenestrated Screw Cement) to be injected into the treated site. This cement is used to augment screw fixation into the pedicle in patients whose life expectancy is of insufficient duration to permit achievement of fusion.

These i mplant s may also ser ve as trad itional p edicle scr ews when use d without b one cement in patients.

CD Horizon™ Fenestrated Screws are specifically designed to connect to appropriate rods and associated connecting components contained within the CD Horizon™ Spinal System. R efer to the CD H orizon™ Spinal System package insert for information regarding those i mplant s. Care sho uld be take n so the corre ct compon ents are us ed in the spi nal construct.

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 s ame constr uct.

To achieve bes t results , do not use CD Ho rizon™ Fenestrated Screw implants with compo nents fro m any system ot her than t he CD Horizon™ Spina l System. As w ith all orthopedic and neurosurgical implants, CD Horizon™ Fenestrated Screw implants should never be reused under any circumstances.

INDICATIONS

When us ed withou t cement, C D Horizon™ Fenest rated Screw s (with or wit hout Sext ant™ or Longitude™ instrumentation) are intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD- defined as back p ain of discog enic ori gin with de generat ion of the di sc confir med by histo ry 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.

Additionally, CD Horizon™ Fenest rated Screw s may be used fo r immobil ization an d stab ilizatio n when used fo r trauma (e .g., frac ture or dis locatio n) with the us age of bone graf t materia l left to the s urgeon’s dis cretion.

When used in conjunction with Kyphon™ HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, or Medtronic HV-R™ Fenestrated Screw Cement, CD Horizon™ Fenestrated Screws are 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, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD Horizon™ Fenestrated Screws augmented with Kyphon™ HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, or Medtronic HV-R™ Fenestrated Screw Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

CONTRAINDICATIONS

Contraindications include:

  Active infectious process or significant risk of infection (immunocompromise).  Signs of local inflammation.  Fever o r leukocy tosis.  Morbid obesity.  Pregnancy.  Mental illness.  Grossly distorted anatomy caused by congenital abnormalities.  Any o ther med ical or surg ical cond ition whi ch would pre clude th e potentia l benef it of

spinal implant surgery such as the presence of congenital abnormalities, elevation of sedim entatio n rate unexp lained by o ther dise ases, elev ation of whi te blood cou nt (WBC), or a mark ed left sh ift in the W BC diffe rential co unt.

 Suspected or documented metal allergy or intolerance.  Pedicular/wall defects.  An a llergy or c ontrain dicatio n to PMMA ceme nt (when used f or the ceme nt-related

indications).

 Any c ase where i mplant co mponent s select ed for use woul d be too larg e or too small t o

achiev e a successfu l result.

 Any patient having inadequate tissue coverage over the operative site.  Any p atient in w hich impl ant use woul d interf ere with an atomical s tructu res or expec ted

physiological performance.

 Any patient unwilling to follow postoperative instructions.

 Any c ase not desc ribed in t he indica tions.  Any p atient wi th a T-score of > -2.5 (whe n cement-augm entatio n is utilize d in patient s

with advanced staged tumors).

ADDITIONAL CONTRAIN DICATIONS (SPECI FIC TO PATIENTS OU TSIDE SCO PE OF PMMA USAG E INDIC ATIO NS)

Nota bene: although not absolute contraindications, conditions to be considered as potent ial facto rs for not usi ng this dev ice includ e:

 Severe bone resorption.  Osteomalacia.  Severe osteoporosis.

POTENTIAL ADVERSE EVENTS

All of t he followi ng adverse e vents asso ciated wit h spinal su rgery wit hout ins trument ation are possible. With instrumentation, a listing of potential adverse events includes:

 Ea rly or late l oosening o f any or all com ponent s.  Disassembly, bending, and/or breakage of any or all 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.

 Pre ssure on the s kin from com ponent pa rts in pa tients wi th inade quate tissu e coverage

over the i mplant p ossibly ca using ski n penetra tion, irr itation , fibros is, necrosi s, 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.  Infectio n.  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 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, 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 s urgery.

 Loss of or increase in spinal mobility or function.  Inability to perform activities of daily living.  Bo ne loss or dec rease in bon e density, po ssibly ca used by stres ses shiel ding.  Il eus, gast ritis, bo wel obstru ction, l oss of bowel con trol, or ot her types o f

gastrointestinal system compromise.

 Hemorrhage, hematoma, occlusion, seroma, edema, hypertension, embolism, stroke,

excessive bleeding, phlebitis, wound necrosis, wound dehiscence, damage to blood vessel s, or other t ypes of car diovascul ar system co mpromise .

 Development of respiratory problems (e.g. pulmonary embolism, atelectasis, bronchitis,

pneumonia, etc).

 Change in mental status.  Death.

Serio us adverse ev ents, som e with fata l outcomes , associate d with the u se of acryl ic 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 repor ts of diag noses beyon d a year or more a fter the p rocedure .

Othe r reporte d adverse eve nts for acr ylic bon e cement s intended f or use in the s pine inclu de leaka ge of the bon e cement beyo nd the site of i ts intend ed applic ation wit h intro duction i nto the vasc ular syst em resulti ng in embol ism of the lu ng and/or hea rt or other clinical sequelae.

Note: ad ditiona l surger y may be necess ary to corr ect some of t hese poten tial

adverseevent s.

IMPORTANT PRODUCT INFORMATION

ADDITIONAL POTENTIAL ADVERSE EVENTS (SPECI FIC TO PATIENTS OU TSIDE SCO PE OF PMMA USAG E INDIC ATIO NS)

 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, ab ove, and/or bel ow the level of s urgery.

 Retropulsed graft.  Herniated nucleus pulposus, disc disruption or degeneration at, above, or below the level

of su rge ry.

  Non-union (or pseudarthrosis), delayed union, and mal-union.  Ce ssation of a ny potentia l growth of t he operat ed porti on of the spi ne.  Gr aft dono r site compl ications i ncludi ng pain, fr acture, o r wound hea ling prob lems.  Reproductive system compromise, including sterility, loss of consortium and sexual

dysfunction.

ADDITIONAL POTENTIAL ADVERSE EVENTS FOR PEDIATRIC PATIENTS (SPECI FIC TO PEDI ATRIC PATIENTS OUTS IDE SCOPE O F PMMA USAGE I NDICATIO NS)

 In abilit y to use pedicl e screw fi xation du e to anatomic l imitat ions (pedi cle dimen sions,

distor ted anatomy).

 Pedicle screw malpositioning, with or without neurological or vascular injury.  Proximal or distal junctional kyphosis.  Pancreatitis.

WARNING

Safet y and effe ctivene ss of pedicl e screw spin al systems h ave been est ablish ed only for spinal conditions with significant mechanical instability or deformity requiring fusion with instr umenta tion. Safe ty and eff ectiven ess of this d evice for any ot her condi tions are unknown. The implants are not prostheses. In the absence of fusion, instrumentation and/ or one or m ore of its com ponent s can be expe cted to pul l out, ben d, or frac ture as a resul t of expos ure to everyd ay mechan ical stres ses. Remov al of these i mplant s used to treat spina l fractu res is left to t he discret ion of the ph ysician an d the patie nt.

A device t hat has bee n implan ted should n ever be reuse d, reproce ssed, or res terilized under any circumstances. Sterile packaged devices should also never be resterilized. Reuse, r eprocessi ng, or reste rilizati on may compr omise the s tructur al integr ity of these impl ants and cr eate a risk of co ntamina tion of the i mplant s which coul d result in pa tient injury, illness, or death.

The following should be noted as warnings and precautions specific to the instruments used in t he injec tion of ceme nt:

Always use live imaging when injecting material.

ement leakage may cause tissue damage, nerve or circulatory problems, and other

 C serious adverse events. These risks may increase with the number of spinal levels where bone cement is used, and also with the volume of bone cement used.

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

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

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 implants are important considerations in the successful use of the system by the surgeon. Further, proper selection and compliance of the patient will greatly affect results. Refer to the Kyphon™ HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, or Medtronic HV-R™ Fenestrated Screw Cement Instructions for Use for cement related contraindications, potential adverse events, and warnings when using those specific cements.

ADDITIONAL PRECAUTIONS FOR PEDIATRIC PATIENTS (SPECI FIC TO PEDI ATRIC PATIENTS OUTS IDE SCOPE O F PMMA USAGE INDICATIONS)

Implantation of pedicle screw spinal systems in pediatric patients should be performed only by ex perien ced spina l surgeons w ith speci fic trai ning in th e use of pedi cle screw spina l system im plants i n pediatr ic patient s becaus e this is a tech nically d emandi ng procedure presenting a risk of serious injury to the patient. Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and proper selec tion and p lacemen t of implan ts are impo rtant co nsidera tions in th e successfu l use of the sys tem in pedi atric pat ients. Th e select ion of the pr oper size, sh ape, and de sign of the impl ant for each p atient is cr ucial to th e safe use of th is device in p ediatri c patient s.

!USA Fo r US Audien ces Only

Caut ion: feder al law (USA ) restric ts these d evices to sal e by or on the ord er of a physici an. Please c ontact Cu stomer Ser vice or you r Sales Rep resentat ive for the m ost up-to-d ate

revisi on of the pack age inser t for curre nt indic ations, wa rnings , precauti ons and oth er important medical information.

FURTHER INFORMATION

IMPORTANT PRODUCT INFORMATION

Important Information on the Kyphon™ HV-R™ Bone Cement

DESCRIPTION

Kyp hon™ HV-R™ Bone Cement is a polymethylmethacrylate (PMMA) that contains approx imately 30 % barium su lfate. It is d esigned fo r deliver y in a highly v iscous sta te.

Table 1: Nominal Composition of Kyphon™ HV-R™ Bone Cement. Actual weight percentages of individual components will vary within accepted ranges

POWDER (20g of s terile powd er in a packet)

Methylmethacrylate-styrenecopolymer 68.0% w/w

Bariu m sulfate 3 0.0% 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, Kyphon™ HV-R™ Bone Cemen t is intende d to restore th e integrit y of the spi nal colum n, even in the a bsence of fusio n for a limite d time in pat ients wit h advanc ed stage tu mors invol ving the t horacic , lumb ar, or sacral sp ine in whom l ife expec tancy is o f insuff icient d uration to p ermit achievement of fusion. Kyphon™ HV-R™ Bone Ce ment is lim ited to use at sp inal level s where t he struc tural int egrity of t he spine is n ot severely co mpromise d.

CONTRAINDIC ATIONS

Kyp hon™ HV-R™ Bone Ce ment is cont raindic ated in the p resence of a ctive or in complete ly treate d infect ion at the sit e where the b one cement i s to be appli ed.

WARNINGS

 T he Ky ph on™ HV-R™ Bone Ce ment is des igned and i ntended f or one time u se only. Do not

re-ster ilize and/or re -use. Steri lity is assu red only if t he unit con tainer is n ot damage d.

 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 as sociated w ith the use of b one cemen ts. Hypot ensive reac tions hav e occurred betwe en 10 and 165 second s followi ng applic ation of bo ne cement , and have las ted from 30 secon ds to 5 or more mi nutes. Som e have progre ssed to card iac arres t. Patien ts 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.

 C ement lea kage may ca use tissue d amage, ne rve or circ ulatory p roblems , and other

serio us adverse ev ents. The se risks

 m ay increase w ith the nu mber of spi nal levels w here bone ce ment is uti lized, and a lso

with th e volume of b one cemen t used.

 C aution sh ould be exe rcised dur ing the mix ing of the t wo compone nts to prevent

excessi ve exposure to t he concent rated vap ors of the mo nomer, which m ay produce irrit ation of th e respira tory trac t, eyes, an d possibly t he liver.

 Po lymeriz ation of the b one cemen t is an exother mic reac tion, whi ch occurs wh ile

the cem ent is hard ening in sit u. The rele ased heat m ay damage b one or othe r tissues surrounding the implant.

 T he liquid c omponen t is a powerf ul lipid so lvent. It s hould not b e allowed to co me into

conta ct with ru bber or late x gloves. Sh ould cont act occur, the g loves may diss olve and tissu e damage ma y occur. Wearing a s econd pair o f gloves and a dherenc e to the mixin g instructions may diminish the possibility of hypersensitivity reactions. The mixed bone cemen t should no t make contac t with the g loved han d until the b one cement i s being tested f or the consi stency of do ugh.

 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, geometry of the mixing apparatus, time spent mixing, and geom etry of the d eliver y device. An y change in o ne or more of t hese condi tions can a lter the handling characteristics of the bone cement, including:

– Han dling per iod - the ti me it takes fo r the bone ce ment to reac h the doughy s tate. The

cement has reached the doughy – sta te when it no lo nger sti cks to surgic al gloves . – Worki ng perio d - the time th e bone ceme nt remain s in the doug hy state and c an be

delivered. – Hard ening pe riod - the ti me it takes fo r the bone ce ment to hard en or until i t can no

longer be delivered.

The use r must be awa re of these fa ctors and a djust tec hnique to ac count for va riabili ty in operating room conditions.

 Avo id over-pressu rization o f bone ceme nt and do not in sert the b one cemen t into

the cav ity of the ve rtebra l body unti l the bone ce ment has rea ched the do ughy stat e. The cem ent has reac hed the do ughy state w hen it no lon ger stic ks to surgica l gloves. Maint ain patie nt positio ning unti l the end of t he polyme rization p rocess. Fail ure to do so may lea d to extrava sation of th e bone ceme nt beyond th e site of its in tended ap plicati on and may or could damage the surrounding tissues.

 Dif ficulty in swallowing and blistering of the throat, alleged to be an allergic reaction to

LIQUID (9.0g o f sterile li quid in a via l)

Methylmethacrylate (monomer) 99.1% w/w

the use o f bone ceme nt, have also b een repor ted.

 D o not mix more t han one vi al of liqui d and one pac ket of powder to gether at a ny one

time. N ever modif y the rat ios betwee n the liqui d and solid c omponen ts. Doin g 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 betwe en the ceme nt and the bo ne, and loo sening of t he bone cem ent may occur, lea ding to fail ure.

 Ky pho n™ HV-R™ Bone Cement is provided in finished form with all the necessary

compo nents for u se. The add ition of ra diopaci fier (e.g . barium , antibiot ics, or ot her drugs or mate rials) to Kypho n™ HV-R™ Bone Ce ment is not re commend ed. Never ad d other subst ances or for eign bodi es to the acr ylic resi n. Safety a nd effec tiveness o f adding su ch drugs or materials has not been evaluated and may cause patient harm.

 M odifyi ng the pol ymerizat ion time by e ither war ming or coo ling the bo ne cement

and/or ass ociated de livery d evices has n ot been teste d and could a ffect b one cement properties, including handling characteristics.

PRECAUTIONS

 Sto re produc t below 25° C. Keep the p roduct at a t emperatu re of 23±1°C for a peri od of

24 hours p rior to use.

 N ever deliv er bone cem ent into the f enestra ted screw wit hout the us e of high qua lity

fluoroscopic guidance capable of visualizing movement of bone cement.

 O nly physic ians thoro ughly tr ained in p edicle scr ew placem ent and the s urgical us e of

bone ce ment shou ld use thes e devices. T he operato r should ha ve specif ic train ing and be familiar with the properties, handling characteristics, and application of the bone cemen t and adher e to the inst ruction s for use.

 D o not use afte r the expi ration dat e printed on t he packag e. The devi ce may not be saf e

or eff ective bey ond its exp iration d ate.

 D o not use if pac kage is ope ned or dam aged beca use produ ct integr ity inclu ding ster ility

may be compromised.

 D o not use dama ged prod ucts. Pr ior to use, ins pect the p ackagin g and produ ct to verif y

that no damage has occurred.

 Follow the mixing and handling instructions to avoid contact dermatitis. Strict adherence

to the in struct ions for mix ing the pow der and liq uid compo nents may re duce 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 c aused by use o f electro cauter y devices in s urgical si tes near fre shly imp lanted bone cements has been reported.

 D ispose of th e polyme r componen t in an autho rized waste f acility. Th e liquid co mponent

can be ev aporated u nder a wel l ventilate d hood or abs orbed by an in ert mate rial and transferred in a suitable container for disposal.

!USA For US A udiences O nly

Caut ion: Federa l law (USA) res tricts t hese device s to sale by or on th e order of a physician.

ADVERSE EVENTS

Serio us adverse ev ents, som e with fata l outcomes , associate d with the u se of acryl ic 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 reports of diag noses beyond a ye ar or more af ter the pro cedure.

Othe r reporte d adverse eve nts for acr ylic bon e cement s intended f or use in the s pine inclu de leaka ge of the bon e cement beyo nd the site of i ts intend ed applic ation wit h intro duction i nto the vasc ular syst em resulti ng in, but no t limited to, e mbolism o f the lung and/or heart or other clinical sequelae.

Othe r reporte d adverse eve nts relev ant to the ana tomy being t reated wit h acryli c bone cements include:

 Deep or superf icial wound infection.  Fis tula.  Hematoma.  Hemorrhage.  E xtrava sation of bo ne cement p otential ly resulti ng in but not l imited to:

– Comp ression or i rritati on of nerv e structu res such as t he spinal co rd or nerve r oots

causing radiculopathy, parasthesia, paraplegia, paralysis, and/or;

– Intr oducti on into the va scular sys tem result ing in emb olism of the l ung and/or h eart or

other clinical sequelae.  P yrexia due to allergy to bone cement.  Short-term conduction irregularities.  Thrombophle bitis.  Transitory fall in blood pressure.  Migration of hardened bone cement bolus.

FURTHER INFORMATION

IMPORTANT PRODUCT INFORMATION

Important Information on the Kyphon™ Xpede™ Bone Cement

Caut ion: Federa l law (USA) re strict s this devi ce to sale by or on t he order of a p hysician. Carefully read all instructions prior to use.

INDI CATIONS FOR U SE

Kyp hon™ Xpede™ Bone Ce ment is ind icated for t he treatm ent of path ologica l fractu res of the ver tebral b ody due to oste oporosis , cancer, or ben ign lesio ns using a cem entoplas ty (i.e. k yphopla sty or ver tebropla sty) proce dure. It is al so indica ted for the f ixatio n of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma and metastatic lesions, including those arisi ng from brea st or lung c ancer, or lymp homa. Ben ign lesio ns includ e hemang ioma 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 vert ebral bod y height .

When used in conjunction with CD Horizon™ Fenestrated Screws, Kyphon™ Xpede™ Bone Cemen t is intende d to restore th e integrit y of the spi nal colum n even in the abs ence of fusio n for a limite d time in pat ients wit h advanc ed stage tu mors invol ving the t horacic , lumb ar, or sacral sp ine in whom l ife expec tancy is o f insuff icient d uration to p ermit achievement of fusion. CD Horizon™ Fenestrated Screws augmented with Kyphon™ Xpede™ Bone Ce ment are fo r use at spina l levels whe re the str uctural i ntegrit y of the spin e is not severely compromised.

STERILE

Kyp hon™ Xpede™ Bone Cement is supplied sterile. The powder and package are sterilized with ga mma radi ation. Th e liquid is s terilized u sing fi ltration a nd is conta ined in a gl ass vial. The out side of th e glass via l is sterili zed with ethy lene oxid e gas. This d evice is inte nded for singl e use only. Do no t resteril ize. Do not use if p ackage is o pen or dama ged.

DEVICE NAME

Kyp hon™ Xpede™ Bone Cement

DESCRIPTION

Kyp hon™ Xpede™ Bone Cement is a polymethylmethacrylate (PMMA) that contains approx imately 3 0% barium s ulfate. It i s designe d for delive ry in a hig hly viscou s state.

Table 1: Nomi nal compos ition of Kypho n™ Xpede™ Bone Cement: (Actual weight percentages of individual components will vary within accepted ranges.)

POWDER (20g of st erile powd er in a packet )

Methylmethacrylate-styrenecopol ymer 69.1% w/w

Bariu m sulfate 3 0.0% w/w N, N-dimethyl-p-toluidine 0.6% w/w

Benzoyl peroxide 0.9% w/w Hydroquinone 75 ppm

CONTRAINDIC ATIONS

PMMA bo ne cement is c ontrain dicated in t he presen ce of active o r incompl etely trea ted infec tion at th e site where t he bone cem ent is to be app lied, for t reatment o f nonpathological, 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 n ot re-steril ize and/or re- use . Sterility i s assured onl y if the unit c ontaine r 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 as sociated wi th the use of bo ne cement s. Hypoten sive react ions have occu rred betwe en 10 and 165 second s followin g applica tion of bone c ement; th ey have lasted from 30 se conds to 5 or mo re minutes. S ome have prog ressed to car diac arres t. 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.

 Ce ment leak age may caus e tissue dam age, ner ve or circul atory prob lems, and ot her

serio us adverse eve nts. Thes e risks may in crease with t he numbe r of spinal lev els where b one cement i s utilized, a nd also wit h the volume o f cement use d.

 C aution sho uld be exerci sed durin g the mixin g of the two com ponents to p revent

excessi ve exposure to t he concentr ated vapo rs of the mono mer, which may pr oduce irrit ation of th e respirato ry trac t, eyes, and po ssibly the l iver.

 Po lymerizat ion of the bo ne cement is a n exothermi c reactio n, which occ urs while t he

cemen t is hardeni ng in situ. Acco rding to the I SO 5833 stand ard, the tem peratur e can be as h igh as 90° C ± 5°C.The rel eased heat m ay damage b one or other t issues surrounding the implant.

 T he liquid co mponent is a p owerful l ipid solve nt. It shou ld not be all owed to come into

conta ct with rub ber or surgi cal gloves . Should con tact occu r, the g loves may diss olve and tis sue damag e may occur. Weari ng a second pai r of gloves and a dherenc e to the

LIQUID (9.0g of s terile li quid in a via l)

Methylmethacrylate (monomer)

99.4% w/w

mixing instructions may diminish the possibility of hypersensitivity reactions. The mixed b one cement s hould not ma ke contact w ith the glo ved hand unt il the bone cemen t is being test ed for the con sistency of d ough.

 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 th e geometr y of the deli very devi ce. Any chan ge in one or mo re of these con ditions can alter the handling characteristics of the bone cement, including the following:

– Han dling per iod – the ti me it takes fo r the bone ce ment to reac h the doughy s tate (the

cemen t has reache d the doug hy state whe n it no longe r sticks to su rgical g loves).

– Worki ng perio d – the time th e bone ceme nt remain s in the doug hy state, an d can be

delivered.

– Hard ening pe riod – the ti me it takes fo r the bone ce ment to hard en or until i t can no

longer be delivered.

 T he user must b e aware of the se factors a nd adjust te chnique to a ccount for va riabili ty

in operating room conditions.

 Avo id over-pressur ization of t he bone ceme nt and do not in sert the b one cement i nto

the ver tebral bo dy until th e bone ceme nt has reache d the doug hy state. The c ement has rea ched the do ughy state wh en it no long er sticks to s urgical g loves. Main tain patie nt position ing until t he end of the p olymeriz ation proc ess. Failure to d o so may lead to ex travasa tion of the bo ne cement be yond the site o f its intend ed applic ation and may or could damage the surrounding tissues.

 T he safety of t he bone ceme nt in pregn ant women or i n children h as not been

established. Bone cement may adversely affect bone growth and fetal health.

 Diff iculty in swallowing and blistering of the throat, alleged to be an allergic reaction to

the use o f bone cemen t, have also b een repor ted.

 D o not mix more t han one via l of liquid an d one packet of p owder toget her at any one

time. N ever modif y the rati os between t he liquid a nd solid com ponents . Doing so ca n 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 bo ne cement an d/or the bone ce ment-bone in terface. A f ibrous t issue layer m ay develo p between th e cement an d the bone, a nd looseni ng of the bon e cement may occur leading to failure.

 Ky pho n™ Xpede™ Bone Cement is provided in finished form with all the necessary

compo nents for us e. The addi tion of Radi opacif ier, e.g. bariu m; antibio tics; or oth er drugs o r material s to Kyphon™ Xpede™ Bone Cement is not recommended. Never add other s ubstance s or foreign b odies to the a crylic re sin. The sa fety and ef fective ness of addi ng such drug s or materia ls has not bee n evaluate d and may caus e patient ha rm.

 M odifyin g the poly merizatio n time by eit her warmi ng or coolin g the bone cem ent

and/or ass ociated de livery de vices has not b een tested an d could af fect bone c ement properties, including handling characteristics.

PRECAUTIONS

 Sto re produc t below 25° C. Keep the p roduct at a t emperatu re of 23 ± 1°C for a pe riod of

24 hours p rior to use.

 N ever deliv er bone cem ent into the ve rtebra l body with out the use o f high qual ity

fluoroscopic guidance capable of visualizing movement of bone cement.

 O nly physic ians thoro ughly tr ained in t he surgic al use of bone c ement and k yphopl asty

or vertebroplasty should use

 Ky pho n™ Xpede™ Bone Ce ment. Th e operator s hould hav e specif ic traini ng and be

familiar with the properties, handling characteristics, and application of the bone cement and ad here to the in struct ions for use .

 D o not use afte r the expi ration dat e printed on t he packag e. The devi ce may not be saf e

or eff ective bey ond its exp iration d ate.

 D o not use dama ged prod ucts. Pr ior to use, ins pect the p ackagin g and produ ct to verif y

no damage has occurred.

 Follow the mixing and handling instructions to avoid contact dermatitis. Strict adherence

to the in struct ions for mix ing the pow der and liq uid compo nents may re duce the incidence of this complication.

 Adequately ventilate the operating room to eliminate as much monomer vapor as

 D ispose of th e polyme r componen t in an autho rized waste f acility. Th e liquid co mponent

can be ev aporated u nder a wel l ventilate d hood or abs orbed by an in ert mate rial and transferred in a suitable container for disposal.

 Use imaging techniques during needle placement and during injection. Extravasation

can occ ur during c ement inj ection if t he needl e is in an art ery or vein , or if unsee n microf racture s are preval ent. Embo lization c an also occ ur if the nee dle is pla ced in an artery or vein. Cement extravasation may cause tissue damage, nerve or circulatory probl ems, and in crease ris k for future f racture s.

 I f bone ceme nt is seen out side of th e vertebr al body/sacru m or in the ci rculator y system

during the procedure, immediately  stop the injection.  Ensure immediate surgical support is available for urgent surgery, if required.

IMPORTANT PRODUCT INFORMATION

ADVERSE EVENTS

Other reported adverse events for acrylic bone cements intended for use in the spine include:

 L eakage of t he bone cem ent beyond th e site of its i ntended ap plicat ion with int roduct ion

into th e vascular s ystem resu lting in, b ut not limi ted to, embol ism of the lu ng and/or

hear t or other cl inical se quelae .  Deep or superf icial wound infection.  Fis tula.  Hematoma.  Hemorrhage.  Heterotopic new bone formation.  E xtravasation of bone cement beyond the site of its intended application potentially

result ing in comp ression or i rritati on of nerv e structu res, such as t he spina l cord or ner ve

roots, causing radiculopathy, parasthesia, paraplegia, or paralysis.  P yrexia due to allergy to bone cement.  Short-term conduction irregularities.  Thrombophle bitis.  Transitory fall in blood pressure.  Migration of hardened bone cement bolus.  E xtravasation of bone cement into sacral foramen or sacroiliac joint potentially resulting

in but no t limited to:

– Compression or irritation of sacral nerve structures causing radicular pain. – Sacroiliac joint dysfunction.

FURTHER INFORMATION

Medtronic

Spinal and Biologics Business Worldwide Headquarters

2600 Sofamor Danek Drive Memphis, TN 38132

Medtronic Sofamor Danek USA, Inc.

1800 Pyramid Place Memphis, TN 38132

(901) 396-3133 (800) 876-3133 Customer Service: (800) 933-2635

medtronic.com

The surgical technique shown is for illustrative purposes only. The technique(s) actually employed in each case will always depend upon the medical judgment of the surgeon exercised before and during surgery as to the best

mode of treatment for eachpatient.

Please see the package insert for the complete list of indications, warnings, precautions, and other important medical information.

Consult instructions for use at this website www.medtronic.com/manuals.

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Medtronic G170059 Technical Manual

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