Page 1
DIRECTIONS FOR USE
CD Horizon™ Medtronic
Rod Connector Set
Featuring offset rods and side-loading/top
and top domino connectors
Page 2
1
CD Horizon™ Medtronic Rod
Connector Set Surgical Technique
M333023W555
Further information
Consult instructions for use (IFU) included with the product and/or at this website
www.medtronic.com/manuals
precautions, and other important medical information.
. The IFU contains the complete list of indications, warnings,
Product name and description
The CD HORIZON™ Spinal System consists of a variety of shapes and sizes of rods, hooks, screws,
CROSSLINK™ Plates, staples and connecting components, as well as implant components from
other Medtronic spinal systems. The components can be rigidly locked into a variety of
configurations, with each construct being tailor-made for the individual case. The Medtronic Rod
Connector (MRC) system, top-loading connectors, side-top loading connectors, and offset rods
provides options for rod-to-rod connection used for extending or providing additional strength to
the existing construct.
No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a
particular purpose or use are specifically excluded.
Please see the package insert for the complete list of indications, warnings, precautions, and other
important medical information.
Consult instructions for use included with the product and/or at this website
www.medtronic.com/manuals.
eManual M#
M333023W555
Other devices referenced in this document
CD HORIZON™ SOLERA™ Spinal System
Page 3
2
CD Horizon™ Medtronic Rod
Connector Set Surgical Technique
M333023W555
Instrument Set Overview
Rod Gauges and Rod Diameter Compatibility
Rod gauges are color-coded to allow quick intraoperative confirmation of rod diameter and match
the range of rod diameters that are compatible with the MRC connectors. If the existing rod does not
fit in the smaller sized notch on the gauge but does fit into the larger notch on the gauge, then select
a connector that matches the color of the gauge. A snug fit on the larger sized notch is preferred for
the closed connection. All MRC 5.5mm titanium closed connectors can be used with 4.75mm rod
diameters (including cobalt chrome rods). Connectors with a top-loading connection are color-
coded to match either 4.75mm and or 5.5/6.0mm rod compatibility. CD Horizon™ spinal system
Medtronic™ rod connector set instrumentation is intended to be used with device and size-specific
implants.
Osteotomes
The efficient removal of a previous fusion mass in the area of a rod-to-rod connection is critical. The
instrument set contains clearing osteotomes to facilitate this step and minimize fusion mass take
down. Straight and angled osteotomes are provided in the set to enable multiple access methods
depending upon the region of the fusion mass and are sized to remove only enough bone to enable
the placement of the connectors.
It is intended for general instruments to be used to remove bone proximal to the existing construct.
Then when close to the existing rod, place the osteotome on the rod where the connector will be
placed and rotate about the existing rod to remove bone. Remove the osteotome and rotate 180°
on the rod and repeat. If needed, the angled osteotome can be used to remove additional bone.
When used in this manner, the osteotomes will experience extended life as the blade ends will not
impact existing hardware and only bone.
Page 4
3
CD Horizon™ Medtronic Rod
Connector Set Surgical Technique
M333023W555
Surgical Options
Compression/Distraction
The closed rod slot connection of the closed/closed and open/closed connectors facilitate
compression and distraction across constructs for sagittal plane correction and closure of
osteotomies.
Preoperative Planning
Primary Surgery
During more complex spinal deformity cases, the independent control of segments of the spine may
be desirable. This may include cases of significant sagittal imbalance or multiple stiff coronal
curvatures requiring multi-rod constructs using rod-to-rod connectors.
For multi-curve patterns, short rod-to-rod connectors like the closed/closed connector may be used.
In the setting of significant sagittal plane deformity where osteotomies are required, sagittal rods
and lateral connectors may be best suited due to the accommodating angle adjustability
offered with these implants. Only patients who meet the criteria listed in the indications
should be selected.
Revision Surgery
Identification of the spinal levels and the existing spinal instrumentation system is one of the most
important aspects of preoperative planning. MRI/CT scans and x-rays (both AP and lateral) are all
necessary presurgical planning tools to determine which connectors are to be used to connect an
existing and new construct. Once the instrumentation is determined to a relatively high degree
of certainty, the add-on construct is planned based on the surgical goals.
CD Horizon™ Spinal system Medtronic™ rod connectors (MRC) offer a wide range of connection
options to enable surgical goals through a variety of implants. This variety enables surgeons to plan
the appropriate addon construct. Once the add-on construct is chosen, select the CD Horizon™
Medtronic™ rod connector that is most appropriate to join the existing CD Horizon™ and
Page 5
4
CD Horizon™ Medtronic Rod
Connector Set Surgical Technique
M333023W555
supplementary constructs. The open side of the side-loading dominos, side-loading/top-loading,
and top-loading/top-loading and the lateral connectors will both accept a range of rod diameters to
accommodate many existing constructs. The ranges are listed below.
• 4.5mm MRC implants accept 4.0mm to 4.5mm rods
• 4.75mm top load implants accept 4.75mm
• 5.5mm/6.0mm top load implants accept 5.5/6.0mm rods*
• 5.5mm MRC titanium implants accept 4.75mm to 5.5mm
rods. The stainless-steel implants will accept 5.0mm
to 5.5mm rods.
• 5.5/6.0 side-loading/top implants accept
5.5mm to 6.0mm rods*
• 6.35mm MRC implants accept 6.0mm to 6.35mm rods
Care should be taken so the correct components are used
in the spinal construct. All parts and necessary instruments
should be present prior to surgery.
Implants
Closed/closed domino connector
The closed/closed domino connector may be used for extensions of a previous fusion or in multi-rod
long spinal
constructs)
compression between
domino connector allows a small offset
width clearance during construct assembly and the 5.5mm size titanium connectors can be used
with 4.75mm diameter
spinal construct.
instrumentation constructs. This includes primary cases with rigid double curves (4-rod
as well as revision cases that may involve smaller osteotomies where rotation and
portions of the spine may require variable displacement. The closed/closed
between the rods. The tear-drop shaped rod channels add
rods. Never use stainless steel and titanium implant components in the same
Page 6
5
CD Horizon™ Medtronic Rod
Connector Set Surgical Technique
M333023W555
When using the counter torque and the self-retaining breakoff driver for final tightening, shear off
the set screws which locks the rods and connectors into place. The break-off set screw has the
appropriate locking torque built into it and should not require additional tightening.
When using the counter torque with the Closed/Closed connector, the appropriate diameter
counter torque should be positioned over the implant with the handle perpendicular to the rod. The
4.5mm Counter Torque (778000014) is compatible with both 4.5mm and 4.75mm rods, while the
5.5mm counter torque (778000013) can be used with both 5.5mm and 6.0mm rods. The 6.35mm
hex break-off driver (7480144) is also compatible when using 4.5mm (7440020) and 5.5mm
(7540020) set screws.
Once in position, rotate the handle medially or laterally and use the 6.35mm hex break-off driver
(7480144) for set screw break-off. After the upper part of the self-breaking set screw has been
sheared off, additional tightening of the set screw is not necessary.
Connector Attributes
• Allows sliding connection
• Bi-directional (can flip around)
• Allows parallel rod connection
• Connection does not have to be co-axial,
can accommodate an angular offset
*5.5mm Closed/Closed Domino Connector Titanium implants can be used with 4.75mm rod
diameters (including Cobalt Chrome rods).
Page 7
6
CD Horizon™ Medtronic Rod
Connector Set Surgical Technique
M333023W555
Side-Loading/closed domino connector
This connector is designed primarily for revision surgeries such as a flexible junctional kyphosis.
Following a small osteotomy, the correction maneuver can be performed by sliding across the
closed portion of the connector. The open side-loading connection permits placement onto an
existing rod. The Side-loading closed domino connector accepts a range of rod diameters.
Using the counter torque and the self-retaining breakoff driver, shear off the set screws which locks
the rods and connectors into place. The break off set screw has the appropriate locking torque built
into it and should not require additional tightening.
When using the counter torque with the side-loading/closed connector, the appropriate diameter
counter torque should be positioned over the implant with the handle perpendicular to the rod. The
4.5mm Counter Torque (778000014) is compatible with both 4.5mm and 4.75mm rods, while the
5.5mm counter torque (778000013) can be used with both 5.5mm and 6.0mm rods. The 6.35mm
hex break-off driver (7480144) is also compatible when using 4.5mm (7440020) and 5.5mm
(7540020) set screws.
Once in position, rotate the handle medially or laterally and use the 6.35mm hex break-off driver
(7480144) for set screw break-off. After the upper part of the self-breaking set screw has been
sheared off, additional tightening of the set screw is not necessary.
Connector Attributes
• Accommodates a range of rod diameters
• Closed side has identical strength as
closed/closed domino
• Allows sliding connection
• Can be connected in the middle of a construct
between existing screws
• Can connect above, below, or
at the previous failure point
• Offers parallel rod connection
Page 8
7
CD Horizon™ Medtronic Rod
Connector Set Surgical Technique
M333023W555
Closed/open axial connector
The closed/open axial connector allows the surgeon to extend a spinal instrumentation construct,
connect broken rods, and allow for variations in rod diameter. The ability to connect rods of varying
diameter makes it particularly suitable for spanning the thoracic region. The closed side of the
connector has identical strength as the closed/closed domino and is most commonly used for
an existing rod while the open side is used for the revision rod.
When using the counter torque with the axial connector, the counter torque should be positioned
over the implant with the handle in-line with the rod. Once in position, rotate the handle
medially or laterally and use the 6.35mm hex break-off driver for set screw break-off. After
the upper part of the self-breaking set screw has been sheared off, additional tightening of the set
screw is not necessary and not recommended.
Connector Attributes
• Allows inline connection of same or different rod diameters
• Open side is compatible with Rocker instrument
for rod seating
• Suitable for transition areas in the spine such as
the thoracic junction
Top/top load connector
The top/top load connector* allows the surgeon to extend a spinal instrumentation construct,
connect broken rods, and allow for variations in rod diameters. There are three top/top load
connector options: 4.75mm to 4.75mm, 4.75mm to 5.5/6.0mm, and 5.5/6.0mm to 5.5/6.0mm.
After removing any bony mass under the existing rod, insert the top/top load connector by sliding it
in under the existing rod. Several different instruments can be used for top/top-loading connector
insertion. For instance, the straight or lateral implant holder combined with the self-retaining hook
pusher (from the CD HORIZON™ SOLERA™ Hook kit) may aid in attaching the connector around a
Page 9
8
CD Horizon™ Medtronic Rod
Connector Set Surgical Technique
M333023W555
previous rod. When using the top load connector, it is recommended to try and keep the rods as
parallel as possible to aid in construct assembly.
The 5.5mm counter torque (778000013) is compatible with the 4.75mm to 4.75mm top/top load
connector loading connector, 4.75mm to 5.5/6.0 and 5.5/6.0mm top loading connector options.
When using the counter torque with the top/top loading connector, place the 5.5mm counter torque
(778000013) positioned over the implant with the handle perpendicular with the rod. Once in
position, rotate the handle medially or laterally and use the set screw breakoff driver (8350316) for
set screw break-off.
Final tightening torque range is 9-10.5Nm or 80-93 in-lbs. for 4.75mm implants and 10.50- 12.50Nm
or 92-110 in-lbs. for 5.5/6.0mm implants.
After the upper part of the self-breaking set screw has been sheared off, additional tightening of the
set screw is not necessary and not recommended.
To use the 4.75mm or the 5.5/6.0mm Torque indicating driver, attach the quick connect t-handle to
the torque indicating driver and pass it through the counter torque and into the inner portion of the
set screw. Turn the handle until the slot reaches the line on the right side of the scale to ensure the
correct torque limit has been achieved.
Connector Attributes
• Allows dual top load connection of same or
different rod diameters
• Offers parallel rod connection to offset rods
• Suitable for transition areas in the spine such as
the thoracolumbar junction
Page 10
9
CD Horizon™ Medtronic Rod
Connector Set Surgical Technique
M333023W555
Side-Loading/top load connector
The Side loading/Top load connector is designed primarily for revision surgeries using 5.5mm or
6.0mm rods. The open side-loading connection permits placement onto an existing rod 5.5mm or
6.0mm rod.
The 5.5mm counter torque (778000013) is compatible with the 5.5/6.0 side-loading/top load
connector loading connector option.
When using the counter torque with the side-loading/top loading connector, place the 5.5mm
counter torque (778000013) positioned over the implant with the handle perpendicular with the rod.
Once in position, rotate the handle medially or laterally and use the set screw breakoff driver
(8350316) for set screw break-off.
Final tightening torque range is 9-10.5Nm or 80-93 in-lbs. for 4.75mm implants and 10.50- 12.50Nm
or 92-110 in-lbs. for 5.5/6.0mm implants.
After the upper part of the self-breaking set screw has been sheared off, additional tightening of the
set screw is not necessary and not recommended.
To use the 5.5/6.0mm Torque indicating driver, attach the quick connect t-handle to the torque
indicating driver and pass it through the counter torque and into the inner portion of the set screw.
Turn the handle until the slot reaches the line on the right side of the scale to ensure the correct
torque limit has been achieved.
Connector Attributes
• Can be connected in the middle of a construct
between existing screws
• Can connect above, below, or at the previous
failure point
• Offers parallel rod connection
Page 11
10
CD Horizon™ Medtronic Rod
Connector Set Surgical Technique
M333023W555
Offset Rods
The Offset rods are available in 5.5mm diameter rods with 11.4 and 13.5mm offsets and 6.0mm
diameter rods with 11.4, 13.5, and 14.2mm offsets. The Offset rods are offered in Titanium and
Chromaloy Plus materials. Never use stainless steel and Titanium implant components together in
the same construct. A rod template (5484510) may be used to measure the rod length required for
the construct. A rod cutter (handheld or table-top) may be used to cut the appropriate rod length.
The offset rod may be bent using small incremental steps using a French bender (7480162). Once
bending is complete use a Rod Introducer/Holder (5584312) to manipulate the rods into the
implants. Reduce the rod into the implants using standard reduction instruments and methods. It is
not recommended to bend the offset rods in the pre-bent region. Offset rods may be used in
conjunction with various connector options. The 3 varying offset rod distances are offered to match
the CD Horizon™ Solera™ Spinal System with Dual Rod Multi-Axial Screw, top-loading/top-loading
connectors, or the MRC 6.35 connectors.
Offset Rod Attributes
• Rod Spectrum: Available in 5.5mm and
6.0mm rod options
• Multiple Material types: Titanium and Chromaloy™ plus
• Available in 3 varying offsets:
• Can be used in conjunction with a connector to extend
above, around or below to a previous construct
* 14.2mm offset is only available in 6.0 rod diameter
11.4mm, 13.5mm, and 14.2mm*
Lateral connector
The lateral connector allows for medial/lateral offset connection of rods to accommodate non-
aligned pedicle screws. The Lateral connector can connect onto a current or existing rod and can be
used with sagittal rods when it is necessary to extend existing spinal stabilization constructs to
additional levels. The Lateral Connector can accept a range of rod diameters.
Page 12
11
CD Horizon™ Medtronic Rod
Connector Set Surgical Technique
M333023W555
When using the counter torque with the lateral connector, the appropriate diameter counter torque
should be positioned over the implant with the handle perpendicular to the rod. Once in position,
rotate the handle medially or laterally and use the 6.35mm hex break-off driver (7480144) for set
screw break-off. After the upper part of the self-breaking set screw has been sheared off, additional
tightening of the set screw is not necessary
Connector Attributes
• Allows a sliding connection
• Can connect above, below, or at the previous
failure point
• Connection does not have to be co-axial,
can have an angular offset
• Variable offset and sagittal angulation
Implant Selection
The selection of the proper size, shape, and design of the implant for each patient is crucial to the success of the
procedure.
Sagittal Rod
The sagittal rod is designed to offer a method for extending instrumentation from a previous
construct and having control over the sagittal contour or alignment between the constructs. The
connector end of the sagittal rod connects to a lateral connector seated onto a rod. The sagittal rod
can be pivoted around the lateral connector and locked in the desired alignment. This permits
angular variation between existing instrumentation and extended levels, avoiding the need for rod
contouring. Sagittal rods can be cut and contoured, if desired. The rods should not be repeatedly or
excessively bent. The rods should not be reverse bent in the same location.
When using the counter torque with the sagittal rod, the appropriate diameter counter torque
should be positioned over the implant with the handle perpendicular to the rod. Once in position,
rotate the handle medially or laterally and use the 6.35mm hex break-off driver (7480144) for set
screw break-off. After the upper part of the self-breaking set screw has been sheared off, additional
tightening of the set screw is not necessary
Page 13
12
CD Horizon™ Medtronic Rod
Connector Set Surgical Technique
M333023W555
Connector Attributes
• May be used for adding-on to constructs,
particularly where sagittal alignment varies
• May be used for revision and fusion extension
in the thoracic region
Implant Selection
The selection of the proper size, shape, and design of the implant for each patient is crucial to the success of the
procedure.
Page 14
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
Telephone: 800 933 2635 (USA)
901 396 3133 (Outside USA)
Fax: 901 396 0356
Medtronic.com
©2022 Medtronic. Medtronic, Medtronic logo and Engineering the extraordinary are
trademarks of Medtronic. All other brands are trademarks of a Medtronic company.
M333023W555
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Telephone: + 31 45 566 80 00
Loading...