Mariner Posterior

TM

Fixation System
Surgical Technique
Table of Contents

Mariner Posterior Fixation System��������������������������������������1

System Features�����������������������������������������������������������1

Surgical Technique��������������������������������������������������������������2

Step 1: Site Preparation������������������������������������������� 2–3

Step 2: Screw Placement�����������������������������������������4–5

Step 3: Rod Selection��������������������������������������������������6

Step 4: Rod Bending����������������������������������������������������6

Step 5: Rod Placement������������������������������������������������7

Step 6: Provisional Tightening�������������������������������������7

Step 7: Rod Reduction���������������������������������������������8–9

Step 8: Compression and Distraction����������������������� 10

Step 9: Final Tightening��������������������������������������������� 11

Step 10: Screw Removal�������������������������������������������� 11

Appendix A – Additional Techniques������������������������������� 12

Appendix B – In Situ Screw Assembly������������������������ 13–15

Product Catalog���������������������������������������������������������� 16–19

Indications for Use������������������������������������������������������������20

Contraindications��������������������������������������������������������������20

Warnings and Precautions������������������������������������������������21

 MarinerTM Posterior Fixation System | Surgical Technique

Mariner Posterior Fixation System

TM

System Features
The Mariner system includes screws that are assemblies of
a variety of components which include a threaded shank
and a rod accepting Screw Head.

• The heads are designed in different configurations that

include Polyaxial, Cephalad/Caudal restricted motion,
and medial/lateral restricted motion Screw Heads.

• The heads are available in standard and extended

heights with break-off tabs.

• The Screw Shanks are available in a variety of length

and diameter size options, and are to be mated to the
Screw Heads via a threaded assembly mechanism either
preoperatively or intraoperatively.

• The rods are provided in multiple length and diameter

options (5.5mm and 6.0mm), in both straight and pre-
contoured configurations.

• T30 Drive is used across shank and Set Screw.

• The Mariner implants are manufactured solely from

titanium alloy (Ti-6Al-4V ELI per ASTM F136).

1
 Surgical Technique
STEP 1 Site Preparation

1A Prepare the pedicle by creating a pilot hole for the screw 1A

using the Awl at the intersection of the articular facet and the
midline of the transverse process. Once the tip of the Awl
is placed at this location, a downward, twisting force shall
be used until the tip of the Awl has penetrated the proximal
cortex of the pedicle. Depth of the penetration is limited to
10mm by the step in the Awl.

NOTE The gold tip of the Awl is 10mm.

The trajectory of the screw through the pedicle, and into the
1B
vertebral body is then created using the Bone Probe at the
entry hole created in the previous step. The Bone Probe,
offered in both straight and curved designs, features indication
markings along the length of the shaft in 10mm increments
(starting at 30mm) to indicate depth in choosing the
appropriate screw length.
1B
NOTE The gold tip of the Probes is 30mm.

1C
Check the integrity of the pedicle walls with the Pedicle
Sounder for any breaches. Using either the Straight or Stiff
Pedicle Sounder, check the interior pedicle walls and anterior
cortex of the vertebral body for any disruptions, breaches or
exposure to neurological structures.

1C

2
 MarinerTM Posterior Fixation System | Surgical Technique

STEP 1 Site Preparation continued

1D
Although the Mariner Pedicle Screws are self-tapping, Taps
1D
are available in various diameters. Taps are true to size and not
undersized. The Taps are modular for attachment to ratcheting
handles and feature depth markings on the tip of the
instrument. Pedicle sounding (in Step 1C) may be performed
following the tapping process in order to ensure there are no
breaches in the pedicle walls.

NOTE The gold tip of the Tap is 30mm.

NOTE It is important to verify the black laser mark on the tap is

not visible after inserting in the Axial Ratcheting Handle. If the
black laser mark is visible, insert the driver until line is not visible.

1E Check the integrity of the pedicle walls with the Pedicle

Sounder for any breaches. Using either the Straight or Stiff
Pedicle Sounder, check the interior pedicle walls and anterior
cortex of the vertebral body for any disruptions, breaches or 1E
exposure to neurological structures. Confirm the appropriate
screw length and diameter using the Screw Sizing Block prior
to placement.

3
 Surgical Technique
STEP 2 Screw Placement

2A Confirm the appropriate screw length and diameter using the 2A

Screw Sizing Block prior to placement.

NOTE It is important to know if surgeon intends on burying the

Screw Head into the bony anatomy. If so, add 3mm to overall length.

Prior to loading onto the screw driver and insertion into the
2B patient, thread the selected Screw Shank onto the desired
Screw Head.
2B
NOTE Refer to Appendix B for shank insertion and in situ head
assembly.

Load assembled Pedicle Screw onto Pedicle Screw Driver

2C by inserting the hexalobe tip into the hexalobe recess of the
Screw Shank. Thread the Pedicle Screw Driver shaft with the
threads at the distal end into the corresponding threads of the
head to secure the screw assembly to the Pedicle Screw Driver.

NOTE All Screw Drivers are compatible with all Pedicle Screw
assembly configurations.

TIP The black laser mark on the proximal end of the driver will not be
visible when loaded correctly.

NOTE Use of the Locking Nut on the Pedicle Screw Driver is 2C

optional. After threading the Pedicle Screw Driver onto screw, slide
the Locking Nut over the proximal end of the Pedicle Screw Driver
shaft into the end of the knob on the Driver Sleeve to lock the Driver
Shaft to the Driver Sleeve.

NOTE When loading the Locking Nut onto the Screw Driver, align
the black laser marks and load into knurled handle.

4
 MarinerTM Posterior Fixation System | Surgical Technique

STEP 2 Screw Placement continued

2D
Insert the screw into the Screw Driver. To disengage the screw
2D
from the Screw Driver, rotate the knob counterclockwise.

NOTE If Inserter Locking Nut was used, pull it proximally toward the
handle prior to rotating knob.

Confirmation of screw positions should be made by

radiographs or intraoperative fluoroscopy.

TIP If a Screw Head does not have polyaxial motion, please rotate
clockwise until motion is restored.

2E To aid in the placement of rods, the head should be aligned

using the Head Turner. Place the Head Turner within the tulip
to adjust the orientation so the rod channels are aligned to the
anticipated direction of the rod.
2E

5
 STEP 3 Rod Selection

3A
The Mariner Posterior Fixation System is compatible with
3A
5.5mm and 6.0mm diameter titanium (Ti6Al4V ELI) rods,
pre-contoured to a variety of lengths.

NOTE It is recommended that the end of the rods extend

approximately 2mm beyond the edge of the Screw Head to
ensure full contact with the Set Screw.

STEP 4 Rod Bending

4A
In the event additional contouring is required, bend the
4A
rod to the desired radius using the French Rod Bender.

CAUTION Avoid repetitive bending and/or notching of the

rod, as this may decrease the fatigue strength.

6
 MarinerTM Posterior Fixation System | Surgical Technique

STEP 5 Rod Placement

Place the rod into the tulip using the Rod Holder.
5A 5A

STEP 6 Provisional Tightening

6A
Once the rod is placed into the channels of the Screw Heads, a
6A
Set Screw is placed by engaging the threads of the Set Screw
into the threads of the Screw Head. The rod is locked within
the screw using a Set Screw.

To insert a Set Screw, insert the hexalobe drive on the distal

6B
end of the Set Screw Starter into the corresponding hexalobe
drive of the Set Screw.

6B

7
 STEP 7 Rod Reduction

The Pistol Rod Reducer is available for quick reduction of a rod

7A 7A
to a single Screw Head. With the outer sleeve fully retracted,
attach to the Screw Head by sliding over the Screw Head until
it snaps into place of the attachment features. Actuate the
handle of the Pistol Reducer until the rod is reduced to the
bottom of the Screw Head. The black laser mark will become
visible when reduction is complete. The Set Screw can now be
inserted.

8
 MarinerTM Posterior Fixation System | Surgical Technique

STEP 7 Rod Reduction continued

7B
Place the Set Screw on the end of the Set Screw Starter or
7B
Final Tightener. Pass the Set Screw through the cannula of
the Pistol Rod Reducer from the proximal end until the Set
Screw meets the Screw Head. Once the Set Screw meets the
Screw Head, engage the threads of the Set Screw into the
threads of the Screw Head. To release from the Screw Head
after reduction, pull the silver release trigger, and toggle from
medial to lateral to disengage.

TIP Prior to loading either the Pistol Persuader or the Axial Reducer,
it is important to verify the instrument is positioned in the fully
opened position.

The Threaded Rod Reducer is available to gradually reduce

the rods into Screw Heads. With the outer sleeve fully
retracted, slide the inner sleeve over the Screw Head until it
snaps into the attachment features on the Screw Head. Turn
the knob clockwise until the rod is fully reduced to the bottom
of the Screw Head. The ‘windows’ will become filled with the
black laser mark when reduction is complete. The Set Screw
can now be inserted. Place the Set Screw on the end of the
Set Screw Starter, then pass the Set Screw through the center
of the Threaded Rod Reducer. To release from the Screw Head
after reduction, turn the knob counterclockwise. Twist the inner
sleeve until the attachment features are disengaged and pull
the instrument away.

CAUTION The Threaded Reducer Extension in conjunction with a

Modular Handle to apply additional torque during the rod reduction
maneuver.

NOTE Both the Threaded Persuader and the Pistol Persuader will
provide up to 30mm of rod reduction.

The Rod Rocker is available for reductions of the rod that are
less than 10mm. Engage the Rod Rocker to the Screw Head by
inserting the prongs into the attachment features of the Screw
Head. Cantilever the Rod Rocker handle back untill the rod is
reduced to the bottom of the rod channel in the Screw Head.

9
 STEP 8 Compression and Distraction

If compression or distraction are required, a Compressor and

8A 8A
Distractor are offered in the Mariner system. To compress or
distract, provisionally tighten one Set Screw which can be used
as a fulcrum.

TIP The Screw Adjuster may be used to quickly loosen or tighten a

Set Screw.

10
 MarinerTM Posterior Fixation System | Surgical Technique

STEP 9 Final Tightening

The Torque-Limiting Adapter is provided to apply the final

9A 9A
tightening torque necessary to secure the construct. Attach the
adapter to the Modular T-Handle along with the Final Driver.

Insert the tip of the Final Driver through the Counter Torque
and into the Set Screw and lower the counter torque over the
Screw Head. Turn the torque handle clockwise and tighten until
an audible click is heard. The clicking indicates that the desired
torque of 85 in-lbs has been achieved.

NOTE The Mariner Posterior Fixation System has a final torque value
of 85 in-lbs or 9.6NM.

STEP 10 Screw Removal

10A
To remove hardware, use the Screw Adjuster for unthreading
10A
both the Set Screw and for removal of the Screw Shank.

11
 Appendix A – Additional Techniques

CrossBar
The CrossBar is designed to provide additional stabilization
A1
and resistance to torsion of the construct by attaching across
from rod to rod. The CrossBar is designed to translate and
rotate about its longitudinal axis and pivot about its midpoint
to provide adjustability to allow it to fit most screw/rod
constructs without the need for bending. The CrossBar comes
in a range of lengths:

Contoured CrossBar
• Small (33mm-41mm) A1
• Medium (39mm-52mm)
• Large (50mm-75mm)
Based on the distance between rods, select the appropriate
A2
CrossBar. Check that the center Set Screw is loose to allow the
CrossBar to pivot about its midpoint. Ensure that the lateral
screws to secure it to the rods at each end are in the open
(down) position. Place the lateral screws over each rod, tighten A2
the clamping screws and finish by tightening the center Set
Screw with the Torque Limiting Driver and Driver Shaft.

NOTE The Crossbar’s in the Mariner set have a final torque of

45 in-lbs.

Extended Tab Heads

The Mariner Extended Tab Heads can be used to reduce
A3
spondylolisthesis as an alternative to using a reducer. The
extended tabs of the head are removed at the end of the
procedure using the Tab Remover, breaking off the extension
A3
tabs flush with the Set Screw once final tightening is achieved.
The Tab Remover is capable of holding up to eight removed
tabs for disposal.

NOTE To remove broken tabs, unthread the blue handle from the
silver shaft. Dump out the broken tabs from the blue handle.

TIP The orientation of the distal tip of the Extended Tab Breaker can
face either medial or lateral.

12
 MarinerTM Posterior Fixation System | Surgical Technique

Appendix B – In Situ Screw Assembly

Mariner allows in situ assembly for Polyaxial Heads and

Extended Polyaxial Heads.

CAUTION In Situ assembly is NOT available for motion limiting

Deformity and Trauma Heads.

After confirming the desired Screw Shank size, attach the

B1
Screw Shank to the Screw Shank Driver. Attach a Modular B1
Ratcheting Handle and insert.

NOTE It is important to verify the black laser mark on the proximal

end of the Shank Drive is not visible after inserting in the Axial
Ratcheting Handle. If the black laser mark is visible, insert the driver
until line is not visible.

13
 Appendix B – In Situ Screw Assembly continued

Insert the shank into the Shank Driver. To disengage the shank
B2 B2
from the Shank Driver, rotate the knob counterclockwise.

NOTE Use the Conical Reamer to remove bone around the Screw
Shank to clear space for attaching the Screw Head and ensure the
surrounding tissue will not limit the movement of the Head.

TIP The Screw Adjuster should be used to further drive or back out
the Screw Shank to adjust the position of the screw in situ.

14
 MarinerTM Posterior Fixation System | Surgical Technique

Appendix B – In Situ Screw Assembly continued

Attach the Polyaxial Screw Head to the Head Inserter. To attach, pull back
on the outer sleeve and slide the inner sleeve over the Screw Head until
it snaps into the attachment features of the Screw Head; release outer
sleeve to lock in place.

NOTE Prior to insertion of the Head onto the Shank, it is important to verify the
Head Inserter is in the ‘locked’ position.

 se the Alignment Shaft to ensure axial alignment of Screw Shank and

U
B3
Screw Head to facilitate threaded attachment. Engage the Alignment
Shaft with drive feature of Screw Shank to achieve alignment. Begin B3
threading Polyaxial Head onto Shank.

NOTE (To Lock) Using the black outer sleeve of the Head Inserter, turn counter-
clockwise towards the ‘Lock.’ Release the outer sleeve. Confirm sleeve is in the
locked position.

B4 When reduced section of Alignment Guide is exposed from handle,

attachment is complete. Remove Alignment Guide and check polyaxial
motion by moving Head Inserter. After ensuring attachment is complete,
pull back on outer sleeve, remove Head Inserter and detach from implant.

NOTE (To Unlock) Using the black outer sleeve, pull proximally towards the
knurled handle, rotate clockwise a quarter of a full turn to a stop and once again B4
pull proximally toward the handle. Toggle the inserter in a medial/lateral motion
to disengage from head.

TIP If a Screw Head does not have polyaxial motion, rotate head clockwise with
Head Turner to restore polyaxial motion.

15
 Product Catalog

Bone Awl Pedicle Probe–Lenke Curved Pedicle Probe–Lenke Straight

PN 90-1101 PN 90 -0013 PN 90-0012

Pedicle–Thin Pedicle–Thick Tap

PN 90-0004 PN 90-0005 PN 90-11dd-1-x

Polyaxial Screwdriver–Locking Screw Shank Driver Conical Reamer

PN 90-1210 PN 90-1220 PN 90-1430

16
 MarinerTM Posterior Fixation System | Surgical Technique

Product Catalog continued

Head Inserter Tissue Retractor Set Screw Starter–Axial

PN 90 -1230 PN 90-1420 PN 90-1305

Screw Depth Adjuster Final Driver Shaft Head Turner

PN 90-0400 PN 90-1701 PN 90-0410

Rod Holder Measurement Block Distractor

PN 90-0501 PN 90-0530 PN 90-0520

17
 Product Catalog continued

Parallel Compressor French Rod Bender Rod Rocker

PN 90-0510 PN 90-0500 PN 90-0610

Pistol Rod Reducer, Multi-Pull Threaded Rod Reducer Threaded Reducer Extension
PN 90-1601 PN 90-1602 PN 90-1532

Inserter Locking Nut Tab Remover Counter Torque

PN 90-1533 PN 90-1531 PN 90-1711

18
 MarinerTM Posterior Fixation System | Surgical Technique

Product Catalog continued

Torque Limiting Adapter, 85 in lb Modular 3mm Hex Driver Connector Torque Handle
PN 90-1700 PN 90-0720 PN 90-0721

Ratcheting Axial Handle, Ratcheting Axial Handle,

Cannulated, 1/4 in sq Cannulated, 1/4 in sq
PN 90-0801 PN 90-0802

19
 Indications for Use Contraindications
The intended use of the Mariner Pedicle Screw System is to Any medical or surgical condition which would preclude
provide immobilization and stabilization of spinal segments the potential benefit of spinal implant surgery is a
in skeletally mature patients as an adjunct to fusion in the contraindication. The following conditions may reduce the
treatment of the following acute and chronic instabilities or chance of a successful outcome and should be taken into
deformities of the thoracic, lumbar and sacral spine. The consideration by the surgeon. This list is not exhaustive:
indications for use are as follows:
Absolute contraindications:
• Degenerative disc disease (DDD) as defined by back
pain of discogenic origin with degeneration of the disc • Infection in or around the operative site
confirmed by patient history and radiographic studies
• Allergy or sensitivity to implant materials
• Severe spondylolisthesis (Grades 3 and 4) of the L5-S1
• Any case not described in the indication
vertebra in skeletally mature patients receiving fusions by
autogenous bone graft having implants attached to the Relative contraindications:
lumbar and sacral spine (L3 to sacrum) with removal of
the implants after the attainment of a solid fusion • Local inflammation

• Spondylolisthesis • Morbid obesity

• Trauma (i.e., fracture or dislocation) • Pregnancy

• Spinal stenosis • Fever or leukocytosis

• Deformities or curvatures (i.e., scoliosis, kyphosis, • Prior fusion at the level(s) to be treated
and/or lordosis)
• G
 rossly distorted anatomy due to congenital
• Spinal tumor abnormalities

• Pseudarthrosis • R
 apid joint disease, bone absorption, osteopenia, and/or
osteoporosis
• Failed previous fusion
• E
 levation of sedimentation rate unexplained by other
diseases, elevation of white blood count (WBC), or a
marked left shift in the WBC differential count

• A
 ny case not requiring bone graft and fusion or where
fracture healing is not required

• P
 atients having inadequate tissue coverage over the
operative site or where there is inadequate bone stock,
bone quality, or anatomical definition

• Unsuitable or insufficient bone support

• Bone immaturity

• T
 he patient’s activity level, mental condition, occupation
and/or a patient unwilling to cooperate with the
postoperative instructions

• A
 ny case where implant utilization would interfere
with anatomical structures or expected physiological
performance

• Use of incompatible materials from other systems

20
 MarinerTM Posterior Fixation System | Surgical Technique

Warnings and Precautions SeaSpine Orthopedics Corporation does not practice

medicine and does not recommend this or any other
Patients with previous spinal surgery at the level(s) to be surgical technique for use on a specific patient. The
treated may have different clinical outcomes compared surgeon who performs any procedure is responsible
to those without previous surgery. The safety and for determining and using the appropriate technique
effectiveness of spinal systems have been established only in each patient.
for spinal conditions with significant mechanical instability
or deformity requiring fusion with instrumentation. These
conditions are significant mechanical instability or deformity
of the spine secondary to severe spondylolisthesis, RxOnly
degenerative spondylolisthesis with objective evidence CAUTION Federal law restricts this
of neurological impairment, fracture, dislocation, device to sale by or on the order of
scoliosis, kyphosis, spinal tumor and failed previous fusion a physician or practitioner.
(pseudarthrosis). The safety and effectiveness of these
devices for any other condition is unknown.
Single Use!
• T
 he implantation of this system should be performed
only by experienced spinal surgeons with specific Implants should never be reused under any circumstances.
training in the use of this device because this is a A used implant should be discarded. While the implant
technically demanding procedure presenting a risk may appear undamaged, it may have small defects or
of serious injury to the patient. internal stress patterns and if implanted, could fail to
perform as intended and pose safety risks to the patient.
• B
 ased on the fatigue testing results, the surgeon should The risks include, but are not limited to, mechanical failure,
consider the levels of implantation, patient weight, breakage, difficulty with implantation, incompatibility with
patient activity level, other patient conditions, etc. mating components and infection.
which may impact the performance of the system.

• E
 nsure all implants, components or instruments are
sterilized prior surgery. The use of non-sterile devices
may lead to inflammation, infection or disease.

• Implants should never be reused under any

circumstances. A used implant should be discarded.
While the implant may appear undamaged, it may have
small defects or internal stress patterns and if implanted,
could fail to perform as intended and pose safety risks
to the patient. The risks include, but are not limited to,
mechanical failure, breakage, difficulty with implantation,
incompatibility with mating components and infection.

• T
 he product has not been evaluated for safety
and compatibility in the magnetic resonance (MR)
environment and has not been tested for heating or
migration in the MR environment.

21
For more information or to place an order, please contact: Manufacturer:
Phone 760.727.8399 USA | Fax 760.727.8809 SeaSpine Orthopedics Corporation
Info@SeaSpine.com | SeaSpine.com 5770 Armada Drive
Carlsbad, CA 92008 USA
Outside USA Phone 760.727.8399 USA | Fax 760.727.8809
Phone #: + 1 866-942-8698
Fax #: + 1 877-558-6227
LAPAC Customer Service:
CustSvcSpine@seaspine.com
Complaints: spinecomplaints@seaspine.com
SeaSpine.com

Warning: Applicable laws restrict these products to sale by or on the order of a physician.
SeaSpine and the SeaSpine logo are registered trademarks of SeaSpine Orthopedics Corporation or its subsidiaries in the United States and/or other countries.
Mariner is a trademark of SeaSpine Orthopedics Corporation or its subsidiaries. ©2017 SeaSpine Orthopedics Corporation. All rights reserved. Printed in the USA.
D0000683C 2017-06 v3