PACH PLATE2 OR 4 HOLE FIXATION

The Science of FusionPACH_v6.indd 1 6/03/2015 7:10 am

The PACH Plate has 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.

PACH Plate Design Rationale

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:• Inabilitytogainsafeaccesstotheanterior

or lateral spine• Acutesuperficialanddeeperinfections• Patientswithinsufficientbonequality

orquantity• Vascularanatomypreventingsafeplacement• Obesepatients

PACH PLATE Design Rationals

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The PACH Plate has 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.

PACH Plate Design Rationale

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:• Inabilitytogainsafeaccesstotheanterior

or lateral spine• Acutesuperficialanddeeperinfections• Patientswithinsufficientbonequality

orquantity• Vascularanatomypreventingsafeplacement• Obesepatients

PACH PLATE Design Rationals

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PACH PLATE SurgicalTechnique

The 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.

StabilityThe 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.

A combination of three different sizes (28mm, 32mm & 36mm) and two different angles (30º & 50º) for both 2-hole and 4-hole plates are available to ensure there are options to fit a wide range of vertebral body anatomy.

SimplicityThe 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.

PACH PLATE Design Rationals

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PACH PLATE SurgicalTechnique

The 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.

StabilityThe 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.

A combination of three different sizes (28mm, 32mm & 36mm) and two different angles (30º & 50º) for both 2-hole and 4-hole plates are available to ensure there are options to fit a wide range of vertebral body anatomy.

SimplicityThe 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.

PACH PLATE Design Rationals

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Positioning the PlateAfter 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 screwsPlate 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 AugmentationThe cancellous bone screws for the Pach Plate are cannulated and fenestrated for cement augmentation in the case of osteoporotic bone. ThetechniqueforcementaugmentationsimplyrequiresaninjectionofPMMAbasedvertebralbody 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.Somecementsystemshaveuniquelockingthreads

and may not be a standard lure lock.

LockingLocking is provided by a spring strip which covers the screw heads after tightening. This system prevents any screw pull out. If removal is required,thescrewscanbeunlockedusingaspecial tool. This tool holds the strip flat in its housing while the screw is loosened. WashingAfter checking for sound final stability of the construct, wash the surgical area thoroughly. ClosingClose plane by plane, install a suction drain at iliac crest level, and if necessary at the surgical area(seldomrequired).

PACH PLATE SurgicalTechnique

PACH_v6.indd 6-7 6/03/2015 7:10 am

Positioning the PlateAfter 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 screwsPlate 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 AugmentationThe cancellous bone screws for the Pach Plate are cannulated and fenestrated for cement augmentation in the case of osteoporotic bone. ThetechniqueforcementaugmentationsimplyrequiresaninjectionofPMMAbasedvertebralbody 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.Somecementsystemshaveuniquelockingthreads

and may not be a standard lure lock.

LockingLocking is provided by a spring strip which covers the screw heads after tightening. This system prevents any screw pull out. If removal is required,thescrewscanbeunlockedusingaspecial tool. This tool holds the strip flat in its housing while the screw is loosened. WashingAfter checking for sound final stability of the construct, wash the surgical area thoroughly. ClosingClose plane by plane, install a suction drain at iliac crest level, and if necessary at the surgical area(seldomrequired).

PACH PLATE SurgicalTechnique

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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 GMP

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