E N V I S I O N®

2

A N T E R I O R C E R V I C A L P L A T E

S U R G I C A L T E C H N I Q U E

O R T H O D E V E L O P M E N T S P I N E

E N V I S I O N®

2 A N T E R I O R C E R V I C A L P L A T E

C O N T E N T S

l . I N T R O D U C T I O N . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

l l . S U R G I C A L E X P O S U R E A N D A P P R O A C H . . . . . . . . . . . . . 2

l l l . P L AT E S E L E C T I O N , C O N T O U R I N G A N D P O S I T I O N I N G . . . . . . 3

l V. T E M P O R A R Y P L A T E F I X A T I O N . . . . . . . . . . . . . . . . . . . 4

V. S C R E W H O L E P R E P A R A T I O N . . . . . . . . . . . . . . . . . . . . 4

V I . S C R E W I N S E R T I O N A N D L O C K I N G . . . . . . . . . . . . . . . . 6

V I l . I M P R O P E R S C R E W S E A T I N G . . . . . . . . . . . . . . . . . . . . . 8

V I l l . S C R E W R E M O V A L . . . . . . . . . . . . . . . . . . . . . . . . . . 1 0

l X . C O L L E T R E P L A C E M E N T . . . . . . . . . . . . . . . . . . . . . . . 1 1

X . C L O S U R E A N D P O S T O P E R A T I V E C A R E . . . . . . . . . . . . . 1 3

E N V I S I O N I N S T R U M E N T C A S E . . . . . . . . . . . . . . . . . 1 4

E N V I S I O N K I T. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 6

A P P E N D I X . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 8

O R D E R I N G I N F O R M A T I O N . . . . . . . . . . . . . . . . . . . . . 1 8

D E S I G N I N G S U R G E O N S :

T h o m a s M . S w e e n e y , M . D . , P h . D . , F. A . A . O . S .Southeastern Spine Center

M a r k B . L o n s t e i n , M . D . , F. A . A . O . S .Sarasota Spine Specialists

The following technique is a general guide for instrumentation of the Envision®2 Anterior Cer-

vical Plate. It is expected that the surgeon is already familiar with the fundamentals of cervical

spinal fusion. Each patient represents an individual case that may require modification of the

technique according to the surgeon’s judgment and experience.

Please see the package insert for intended uses/indications, device description, contraindications, pre-

cautions, warnings and potential risks associated with the Envision®2 Anterior Cervical Plate.

U.S. Federal Law restricts this device to sale by or on the order of a physician.

I l l u s t r a t i o n s Jill Rhead, M.A.

l . I N T R O D U C T I O N

The Envision®2 Anterior Cervical Plate offers a unique blend of features engineered for ease-of-use and superior

clinical results. The rotationally-dynamic design enables load-sharing between implant and graft for a more reliable

fusion. It has a seamless, “no-step” self-locking mechanism while maintaining a low profile (2.0mm) that virtu-

ally eliminates soft tissue irritation. And, with large central fenestrations and a narrow footprint, the Envision®2 Anterior

Cervical Plate provides superior visualization of the interbody space.

T H E E N V I S I O N®

2 A N T E R I O R C E R V I C A L P L AT E I N C O R P O R AT E S T H E L AT E S T

I N C E R V I C A L P L AT E T E C H N O LO GY F O R S P I N A L F U S I O N .

1

S T R E N GT H A N D F L E X I B I L I T Y

The Envision®2 Anterior Cervical Plate offers a unique

blend of flexibility and strength, which increases load-

sharing and decreases the potential for implant fracture.

S E L F - LO C K I N G S Y S T E M

The Envision®2 Anterior Cervical Plate patented self-

locking mechanism automatically locks screws to the plate

during insertion. The mechanism employs both a rim lock

and a taper lock within the collet to minimize the potential

for screw backout and to provide audible, visual and tactile

indicators of locking mechanism engagement.

T H I N A N D N A R R O W

The Envision®2 Anterior Cervical Plate has a thin

(2mm) and narrow (16mm) design to minimize soft

tissue irritation and accommodate patient anatomy.

L A R G E G R A F T W I N D O W S

The Envision®2 Anterior Cervical Plate provides excel-

lent visualization of the graft and vertebral endplates

during placement of the plate.

1

2

3

4

1

2

3

4

l l . S U R G I C A L E X P O S U R E A N D A P P R O A C H

The patient is placed on the operating room table in the supine position with the head in slight extension and slight rotation

opposite the side of incision. The laryngeal nerve that controls the voicebox runs on the right side of the neck. The incision

is typically left sided so as to avoid potential post-op speech problems. Following appropriate positioning and padding, the

patient is prepped and draped in a sterile manner. A horizontal incision is made in the skin within a skin fold, if possible. The

incision is divided sharply. Electro-cautery can be used to control bleeding. Dissection then continues down to the level of the

subcutaneous tissue and platysma. The platysma is either divided or incised and retracted, allowing access to the fascial plane

between the sternocleidomastoid and “strap muscles.” The dissection is carried down to the level of the anterior aspect of the

spine, where the prevertebral fascia is incised using scissors and then dissected along the disc space using standard dissection

techniques. A spinal needle is used to mark the disc space; placement is verified via an intraoperative X-ray.

Having confirmed the appropriate level, a cervical dis-

traction set can be used with distracting pins in the up-

per and lower vertebral body. Gross dissection is then

performed using a #11 blade and pituitary rongeur. If

desired, an operating microscope can be used. Using mi-

cro curettes and rongeurs, completion of the discectomy

and/or corpectomy can be performed to the level of the

posterior longitudinal ligament. Removal of the poste-

rior longitudinal ligament can be performed to expose

the dura. (Figure 1) Having completed the discectomy,

the end plates are decorticated and posterior osteophytes

are removed, if necessary.

Interbody bone grafting is then performed for each disc

space or motion segment to be fused. Prior to placing

plates, all anterior osteophytes are removed to allow

placement of the plate on a smooth surface.

2

F I G U R E 1

l I I . P L A T E S E L E C T I O N , C O N T O U R I N G A N D P O S I T I O N I N G

When selecting the appropriate plate, it is important to know that the nominal length is based on the distance between screw

hole centers. The overall plate length is 8mm longer than the stated nominal length (see Appendix, Figure A).

The Plate Holder may be used to hold the plate against the cervical vertebrae for plate size selection. The Plate

Holder mates with the plate by grasping the section between any two screw hole pairs (Figure 2). To avoid en-

croachment into adjacent levels, the appropriate plate length is determined by placing the superior and inferior

screw holes close to the disc or corpectomy space being fused.

After an appropriate plate size has been selected, the

plate is positioned on the anterior surface of the verte-

bral body. Mediolateral and caudocranial position is then

confirmed.

The Envision®2 Anterior Cervical Plate is pre-contoured

for an average lordotic curve and vertebral body diameter.

In most cases, this standard geometry will be adequate. If

needed, the lordotic curvature of the plate may be modified

using the Plate Bender* (Figure 3).

It is recommended that the Plate Bender be adequately

lubricated with surgical instrument lubricant. To modify

the lordotic curve, carefully attach the cervical plate to the

Plate Bender and bend the plate to the desired curvature

within the “bending zones.” *

Excessive and/or reversed bending of the plate should be

avoided as this can significantly weaken the plate.

*Note: A ‘bending zone’ is the area between the screw-hole pairs. If

a plate is bent through the screw holes, the locking mechanism will

be damaged.

3

F I G U R E 2

F I G U R E 3

P L AT E H O L D E R

C E R V I C A L P L AT E

P L AT E B E N D E R

I V . T E M P O R A R Y P L A T E F I X A T I O N

After correct positioning of the plate has been established, a Fixation Pin may be used to provide stability during screw

placement. The Fixation Pin may be inserted through any of the screw holes using the Hex Driver (Figures 4 and 5).

Note: The Fixation Pin is designed for single use.

4

F I G U R E 4F I G U R E 5

V. S C R E W H O L E P R E P A R A T I O N

S E L F - D R I L L I N G

In preparation for screw insertion, the Punch may be used

to create a pilot hole. The Punch will center the pilot hole

in the screw hole of the plate; otherwise, the screw might

not lock to the plate. The Punch is placed in the desired

screw hole, angled up to 15°, and gently pressed into the

bone while rotating the handle about its axis (Figure 6).

The depth stop on the Punch provides for a pilot hole that

is 10mm deep.

S E L F - T A P I N G

Alternately, the pilot hole can be drilled. Both Hand

Drills and Power Drills are provided (Figure 7). A Single

Barrel Guide is provided for use with the two drill types

to center the drilled pilot holes in the screw holes.

F I G U R E 6

H E X D R I V E R

F I X AT I O N P I N

P U N C H

P U N C H

P L AT E H O L D E R

F I G U R E 7

The tip of the Single Barrel Guide is placed inside the collet of the plate

(Figure 8). This mate allows the surgeon to vary the angle for the pilot hole

in any direction. It is important to take care and limit the angle to 15° in any

one direction or the subsequently placed screw might not lock to the collet.

The main function of the Single Barrel Guide is to insure the pilot hole is

centered in the screw hole of the plate; otherwise, the screw might not lock to

the plate. The Single Barrel Guide also functions with the Drills to produce

a known pilot hole depth (the created pilot hole will be approximately 1mm

deeper than the corresponding screw).

Select the appropriate Drill for the corresponding screw length. Screws and

Drills are color matched for easy length identification (12mm: Green; 14mm:

Blue; 16mm: Magenta). Place the Drill through the Single Barrel Guide and

advance the Drill into the vertebral body to the depth allowed by the stop

on the Drill.

The Tap is provided for use in those rare cases where dense bone might

make screw advancement difficult. The Tap can be placed through the Single

Barrel Guide and advanced as far as the stop allows. This creates a tapped-

hole depth of 10mm.

5

F I G U R E 8

S I N G L E B A R R E LG U I D E

6

F I G U R E 1 0 F I G U R E 1 1

C O L L E T 1 - 2 M M

P L AT E

S C R E W

F I G U R E 9

H E X D R I V E R

V l . S C R E W I N S E R T I O N A N D L O C K I N G

Prior to screw insertion, it is good practice to clean any debris from the

screw hole. Debris may prevent the screw from fully seating and thus the

screw might not lock to the plate. The selected screw is inserted using the

Hex Driver. The mate between the Hex Driver and cervical screw is self-

retaining. This is achieved by gently pressing the Hex Driver into the hex

of a screw within the screw caddy. The Hex Driver is then used to drive

the screw into position (Figure 9).

P R O P E R I N S E R T I O N

The correct way to insert a screw into the collet and secure the Envision®2

Anterior Cervical Plate is demonstrated in the figures below:

Figure 10 - Illustrates a screw fully seated and properly locked in the collet.

Note: Fully seated, the head of the screw seats 1-2mm below the rim of the collet.

Figure 11 - Cutaway view that conveys the design intent of the screw

properly seated in the collet locking mechanism.

7

K E Y P O I N T S

• Listen for an audible click as the screw passes the anterior collet rim, followed by taper engagement. Look for the

position shown in Figures 10 and 11.

• Tightening the screw completely will lock the screw to the plate.

Two features are employed to lock the screw to the plate. The first feature is a rim on the collet that first expands

to allow the entrance of the screw and then retracts to keep the screw in place. The second feature is a Morse taper

that cold welds the screw to the collet (Figure 12). The rim will likely click as the screw passes into the collet. Then,

an additional 1 to 2 revolutions of the Hex Driver should suffice to engage the Morse taper. Resistence increases as

the Morse taper engages.

Note: It is good practice to visually inspect the screw after final tightening to ensure that the screw is seated fully in the collet,

below the locking rim, and that the collet is properly aligned within the plate screw hole.

F I G U R E 1 2

V l l . I M P R O P E R S C R E W S E A T I N G

While the Envision®2 Cervical Plate locking mechanism is one of the easiest to employ, it is still important to

distinguish between proper and improper screw seating. Therefore, once the screw is completely seated visual and

tactile verification will ensure that the locking mechanism will function as designed.

I M P R O P E R I N S E R T I O N

The figures below illustrate a screw that has been inserted and is flush with the collet, but is not fully seated in the collet.

Figure 13 - Illustrates a screw that is flush but not fully seated or properly locked in the collet.

Figure 14 - Cutaway view that conveys an improperly seated screw.

K E Y P O I N T S

• Although a screw may appear locked, a surgeon may falsely perceive that a screw is fully seated. A screw in this

position may present the appearance and tactile feel of a locked screw.

Note: If a screw is not fully seated or properly locked to the collet it will have an increased chance of back-out. Therefore it

is important to be certain that components are locked. Ambient noise may conceal the “click” and individual sensitivities

may cause false perception. Blood and tissue may impair visual verification. Therefore tactile feel may verify seating.

F I G U R E 1 3 F I G U R E 1 4

C O L L E T

P L AT E

S C R E W

8

Screw angle variability is achieved via the spherical collet in the plate.

This collet/plate interface accommodates up to 15° of angulation in

any direction (30º total) (Figure 15).

The locking mechanism of the Envision®2 Anterior Cervical Plate

has a working limit of 30º in screw angle variability. If the 30º

variability in screw angle is exceeded, the locking mechanism will

not function, which will greatly increase the likelihood of screw

back-out, and associated complications.

9

F I G U R E 1 5

S C R E W P A S S T H R O U G H

On occasion, an audible “click” is not heard or felt. If the “click” is not heard or felt, the user may then have

an inclination to continue tightening. Normally, an obvious tactile sensation of taper engagement is felt. A stopping

point is typically felt shortly (1-2 revolutions) after the audible click is heard or felt. The taper locking

mechanism is engaged at this point. Screw threading must cease 1-2 revolutions after the screw head passes the

anterior rim of the collet. Otherwise, a screw may be drawn completely through the collet and void the taper

locking mechanism.

15º15º15º15º

V l I I . S C R E W R E M O V A L

The cervical screws can be removed by simply reversing the

direction of driving, the removal of the screw will per-

manently deform the screw and collet, rendering them

both unusable. Note that repetitive threading of the

screw into the bone can decrease bone quality and screw

purchase.

If needed, the Screw Remover (Figure 16) may be used

to back a locked screw out of the cervical plate. This

will remove the collet from the plate. To do this, thread

the tip of the Screw Remover into the internal hex of the

screw by twisting the handle counter-clockwise. Then

twist the outer sleeve of the Screw Remover clockwise

until it contacts the plate. While holding the outer sleeve

of the Screw Remover against the plate, continue to

twist the handle of the Screw Remover counter-clock-

wise to thread the cervical screw out of the bone.

F I G U R E 1 6

10

S C R E W R E M O V E R

H A N D L E

O U T E R S L E E V E

11

F I G U R E 1 7

F I G U R E 1 8

K N O B

C O L L E T R E V I S I O N T O O L

C O R R E C T I N C O R R E C T

C O L L E T M A G A Z I N E

I X . C O L L E T R E P L A C E M E N T

Cervical plates are provided with the collets already installed. Nevertheless, in instances when a locked screw is re-

moved, the corresponding collet must be replaced. This is accomplished with the Collet Revision Tool and the

Collet Magazine (Figure 17).

The Collet Revision Tool is used to remove used collets from the plate and to insert replacement collets into the

plate. To engage a collet with the Collet Revision Tool, press the tip of the Collet Revision Tool into the collet and

lock its tip to the collet by tightening the knob at the top of the tool handle.

12

Improper orientation of the collet (i.e., upside down) would pre-

vent the screw from locking to the collet and could result in

screw back-out. It is good practice to retrieve new collets di-

rectly from the Collet Magazine with the Collet Revision Tool

to insure that the collet is oriented correctly. (Figure 18).

To remove a new collet from the cervical plate first, insert the

Collet Revision Tool into the collet. Next, tighten the knob on

the Tool. Using a rocking and swiveling motion with the Collet

Revision Tool the collet will release. (Figure 19).

Note: The collet cannot be directly pulled from the plate.

To install a collet, first retrieve a collet with the Collet Revision

Tool from the Collet Magazine; the knob in the Collet Revision

Tool must be loose. Next, tighten the knob to secure the collet.

The new collet is then installed in the plate by rocking and swiv-

eling the collet into the appropriate screw hole (Figure 20).

The collet cannot be impacted into place. The feeling of seating

the collet into proper position in the screw hole of the plate is

apparent. Ensure that the collet is fully seated in the plate by

spinning the collet about its axis to ensure the collet rotates free-

ly in the screw hole. The knob of the Collet Revision Tool is

then loosened to release the replaced collet.

F I G U R E 1 9

F I G U R E 2 0

13

X . C L O S U R E A N D P O S T O P E R A T I V E C A R E

After visual inspection and radiographic confirmation of optimal placement of the plate, screws, and bone graft, the wound

is irrigated with copious fluids. The wound is then closed over a drain, if desired. Closure technique is per

surgeon preference.

Collars may be used as indicated for patient comfort or for individual cases of decreased bone density after assessment of

quality. Always take routine postoperative radiographs.

14

E N V I S I O N®

2 A N T E R I O R C E R V I C A L P L A T E I N S T R U M E N T S

Cervical Plate

Single Barrel Guide

Punch

Power Drill

Collet

Hand Drill

Hex Driver 2.5mm

Bone Tap

15

Plate Holder

Collet Magazine

Fixation Pins

Cervical Screws

Screw Remover

Plate Bender

Caliper

Collet Revision Tool

16

E N V I S I O N®

2 A N T E R I O R C E R V I C A L P L A T E K I T

Envision Kit 254-9003

MIDDLE BOTTOM

PART NO. DESCRIPTION QTY

254-6002 Cervical Plate Instrument Case

254-0007 Punch 1

254-1003 Bone Tap 1

254-1004 Fixation Pin 4

254-1005 Single Barrel Drill Guide 1

254-1006 Plate Bender 1

254-1008 Internal Hex Driver 2.5mm 2

254-1009 Screw Remover 1

254-1010 Plate Holder 1

PART NO. DESCRIPTION QTY

254-1015 Collet Revision Tool 1

254-1016 Collet Magazine 1

254-1312 Drill 12mm 1

254-1314 Drill 14mm 1

254-1316 Drill 16mm 1

254-2312 Power Drill 12mm 1

254-2314 Power Drill 14mm 1

254-2316 Power Drill 16mm 1

254-0011 Caliper 1

154-1000 Collet 10

CASE TOP TOP

17

N O T E S

12187 South Business Park Drive

Draper, Utah 84020

Telephone: 801.553.9991

Fax: 801.553.9993

For more information visit

www.orthodevelopment.com

Ortho Development and all other registered trademarks and trademarks are the property of Ortho Development Corporation. Patent(s) pending. Part No. 351-1-10739 REV 04/2015

A P P E N D I X O R D E R I N F O R M A T I O N

PRODUCT # LEVEL NOMINAL ACTUAL LENGTH LENGTH

154-5114 One 14mm 22mm

154-5116 One 16mm 24mm

154-5118 One 18mm 26mm

154-5120 One 20mm 28mm

154-5122 One 22mm 30mm

154-5124 One 24mm 32mm

154-5226 Two 26mm 34mm

154-5228 Two 28mm 36mm

154-5230 Two 30mm 38mm

154-5232 Two 32mm 40mm

154-5235 Two 35mm 43mm

154-5238 Two 38mm 46mm

154-5241 Two 41mm 49mm

154-5244 Two 44mm 52mm

154-5247 Two 47mm 55mm

154-5346 Three 46mm 54mm

154-5349 Three 49mm 57mm

154-5352 Three 52mm 60mm

154-5355 Three 55mm 63mm

154-5358 Three 58mm 66mm

154-5361 Three 61mm 69mm

154-5364 Three 64mm 72mm

154-5367 Three 67mm 75mm

154-5460 Four 60mm 68mm

154-5465 Four 65mm 73mm

154-5470 Four 70mm 78mm

154-5475 Four 75mm 83mm

154-5480 Four 80mm 88mm

154-5485 Four 85mm 93mm

154-5490 Four 90mm 98mm

154-5495 Four 95mm 103mm

C E R V I C A L P L A T E( F I G U R E A )

S E L F - D R I L L I N G S C R E W( F I G U R E B )

GREEN 12mm

BLUE 14mm

MAGENTA 16mm

D R I L L C O L O R M A T C H I N G

S E L F - T A P P I N G S C R E W ( F I G U R E C )

F I G U R E A

16 m m

NO

MIN

AL

AC

TU

AL

2 m m

LE

NG

TH

F I G U R E B

LE

NG

TH

F I G U R E C

154-6012 4.0mm 12mm Light Green

154-6014 4.0mm 14mm Light Blue

154-6016 4.0mm 16mm Light Magenta

154-6312 4.35mm 12mm Dark Green

154-6314 4.35mm 14mm Dark Blue

154-6316 4.35mm 16mm Dark Magenta

PRODUCT # SIzE ACTUAL COLOR (DIAMETER) LENGTH

PRODUCT # SIzE ACTUAL COLOR (DIAMETER) LENGTH

154-6240 4.0mm 12mm Light Green

154-6440 4.0mm 14mm Light Blue

154-6640 4.0mm 16mm Light Magenta

154-6243 4.35mm 12mm Dark Green

154-6443 4.35mm 14mm Dark Blue

154-6643 4.35mm 16mm Dark Magenta