THE SCIENCE OF FUSION

PACH PLATE2 OR 4 HOLE FIXATION

ORTHOTECH PTY. LTD.

51 SANDGATE ROAD, ALBION, QLD 4010

PO BOX 203, ALBION, QLD 4010

TEL: +61 7 3262 5033

FAX: +61 7 3262 5099

ORTHOTECHGROUP.COM

MANUFACTURED BY

A-SPINE ASIA CO. LTD.

11F, NO 1, ALLEY 30, LANE 358, RUIGUANG ROAD, NEIHU DISTRICT, TAPEI CITY, TAIWAN

TEL +886 2 2627 2977

FAX +886 2 6606 5955

08030-044

PACH PLATE DESIGN RATIONALE

The PACH Plate whas been designed to be used as an anterior or lateral fixation plate for the thoracolumbar, lumbar and lumbosacral spine. The Pach Plate provides primary fixation for an interbody device which can avoid the need for supplementary posterior fixation.

The Pach Plate is indicated for use via an anterior, anterolateral or lateral surgical

approach as an adjunct to interbody fusion. It is indicated for the treatment of spine

instability as a result of fracture (including dislocation and subluxation), tumour, scoliosis,

kyphosis, spondylolisthesis and degenerative disc disease (defined as discogenic pain

with the disc degeneration confirmed by radiographic studies and patient history).

The PACH secured anterior plate is made of TA6V titanium alloy (per ASTM F 136 or ISO

5832 standards) making it MRI compatible.

CONTRAINDICATIONS

• I nability to gain safe access to the anterior or lateral spine

• Acute superficial and deeper infections

• Patients with insufficient bone qualityor quantity

• Vascular anatomy preventing safe placement

• Obese patients

03 04 DESIGN RATIONALE DESIGN RATIONALE

05 DESIGN RATIONALE 06DESIGN RATIONALE

Stability

The Pach Plate is shaped to fit the natural lordotic curvature of the spine and

contributes to the stability of the spine when used in conjunction with an interbody

device.

The 2-hole plate option is specifically designed with a smaller footprint for a lateral

approach. Additionally, two 2-hole plates can be used anteriorly in place of a 4 –hole

plate depending on vascular and vertebral anatomy.

Simplicity

The Pach Plate is a simple, yet comprehensive stabilisation solution for multiple

approaches to the spine. The simplistic design of the instrumentation allows for

efficient implantation and reduced surgical steps.

The plate geometry and the ridge above the distal screw holes allow for easy

placement and the incorporated locking mechanism eliminates additional locking

steps reducing the operative time.

REF CODE DESCRIPTION

1 1017-30328 4 HOLE PACH PLATE 32MMX30DEG YELLOW

2 1016-30328 2 HOLE PACH PLATE 32MMX30DEG YELLOW

3 1016-30288 2 HOLE PACH PLATE 28MMX30DEG GRAY

4 1017-30288 4 HOLE PACH PLATE 28MMX30DEG GRAY

5 1017-50328 4 HOLE PACH PLATE 32MMX50DEG GREEN

6 1016-50328 2 HOLE PACH PLATE 32MMX50DEG GREEN

7 1016-50288 2 HOLE PACH PLATE 28MMX50DEG BLUE

8 1017-50288 4 HOLE PACH PLATE 28MMX50DEG BLUE

9 1017-30368 4 HOLE PACH PLATE 36MMX30DEG LIGHT BLUE

10 1016-30368 2 HOLE PACH PLATE 36MMX30DEG LIGHT BLUE

11 1016-50368 2 HOLE PACH PLATE 36MMX50DEG PURPLE

12 1017-50368 4 HOLE PACH PLATE 36MMX50DEG PURPLE

13 1019-50268 PACH PLATE SCREWS 5X26MM YELLOW

14 1019-50288 PACH PLATE SCREWS 5X28MM BLUE

15 1019-50308 PACH PLATE SCREWS 5X30MM PURPLE

16 407-1404 INTRODUCER

17 407-2602 CEMENT PUSHER

18 1050-06018 (RHR) Blue Small Screw Locking Cap

19 1050-06028 (RHS) Yellow Large Screw Locking Cap

07 SURGICAL TECHNIQUE 08 SURGICAL TECHNIQUE

Positioning the Plate After the appropriate interbody fusion device is implanted, the Pach Plate is

placed over the intervertebral disc space using the plate holder. The screw

holes in the plate should be located on the vertebral bodies above and below

the treated level. There is a ridge above the distal internal surface of the

plate to provide a secure seat on the cortical rim of the inferior vertebral

body. For maximum stability, two plates may be fitted. 4-hole and 2-hole

plates can be used in an anterior approach while only 2-hole places can be

used in a lateral approach. N.B. The plates are available in several lengths and angles to meet

varied segment heights and angles.

Inserting screws Plate fixation to the vertebral bodies is provided by cancellous bone screws.

An awl is used to create pilot holes through the screw holes in the plate for

screw insertion. The screws fit into the angled circular screw holes of the

plate. The screw angle can be varied within +/- 30º. The screw is tightened

using a 3mm hex screwdriver which fits into the hexagonal stamp located on

the upper side of the screw. The screw length must be determined through

pre-operative imaging. A spring strip which covers the screw heads after

tightening prevents screw back out.

Cement Augmentation

The cancellous bone screws for the Pach Plate are cannulated and fenestrated for cement augmentation in the case of osteoporotic bone.

The technique for cement augmentation simply requires an injection of PMMA based vertebral body cement through a provided cannula

into the head of the screws. The fenestration in the screws is the same distance from the screw head in each of the screw lengths. The

cannula provided in the Pach Plate set fits a standard lure lock syringe. N.B. Some cement systems have unique locking threads and may not be a standard lure lock.

Locking

Locking is provided by a spring strip which covers the screw heads after tightening. This system prevents any screw pull out. If removal is

required, the screws can be unlocked using a special tool. This tool holds the strip flat in its housing while the screw is loosened.

Washing

After checking for sound final stability of the construct, wash the

surgical area thoroughly.

Closing

Close plane by plane, install a suction drain at iliac crest level, and

if necessary at the surgical area (seldom required).

PACH PLATE SURGICAL TECHNIQUEThe Pach Plate can be implanted via a retroperitoneal, transperitoneal or lateral approach to the spine.

Disclaimer: The surgeon performing the procedure must be appropriately trained in the chosen approach to the spine.