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ROI-C
CERVICAL CAGE
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SURGICAL TECHNIQUE
Table of Contents
Surgical approach and discectomy
Trialing
Implant insertion
Plate insertion
Implant Holder removal and final assessment
Removal or revision
Device description and use guidelines
The surgical
technique is for illustrative purposes only. The
technique(s) actually employed in each case will
always depend upon the medical judgement of the
surgeon exercised before and during surgery as to
the best mode of treatment for each patient.
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Indications (United States)
 When used as an intervertebral body fusion device,
the ROI-C Implant System is indicated for use
in skeletally mature patients with degenerative
disc disease (DDD) of the cervical spine with
accompanying radicular symptoms at one disc level
from C2-T1. DDD is defined as discogenic pain with
degeneration of the disc confirmed by history and
radiographic studies. These patients should have
had six weeks of nonoperative treatment. The ROI-C
implants are to be used with autogenous bone
graft and implanted via an open, anterior approach.
Supplemental internal fixation is required to properly
utilize this system.
NOTE: VerteBRIDGE® Plating is the supplemental
fixation designed specifically for the ROI-C cage and
can be used in applications where a
stand-alone anterior construct is appropriate.
Additional supplemental fixaton options can be
used with ROI-C cage (with or without VerteBRIDGE
Plating) include posterior screw/rod systems or
additional vertebral plating.
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Surgical approach and discectomy
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Step 1
Surgical approach
Identify the affected level radiographically and perform a customary ACDF approach.
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Distraction
Distract as necessary to achieve adequate access to
the disc space.
If using a Caspar Distractor, the pins must be placed
midline and at least 7mm from both endplates
surrounding the disc being replaced to avoid
contact between the Caspar Pins, the Implant Holder
(MC9001R), and ROI-C plates.
Remove Caspar Pins prior to plate advancement to
eliminate any risk of plate obstruction.
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Discectomy
Perform a thorough discectomy to remove the disc down to the osseous endplates. Prepare the endplates just
enough to create a surface that will encourage vascularization between the endplates and the graft without
weakening cortical bone.
CAUTION: The anatomic shape of the ROI-C implant requires preservation of the endplates, including the superior
endplate dome. Endplate removal may increase the risk of subsidence and necessitate supplemental fixation in addition
to the ROI-C plate.
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Trialing
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Step 2
Depth assessment
Place the hook of the Depth Gauge (MB906R) just over the posterior edge of the
inferior vertebra.
To achieve the most accurate reading, position the Depth Gauge as medial as
possible and completely remove all anterior and posterior osteophytes.
View the depth reading at the end of the Depth Gauge and determine if the 12
or 14mm depth implant will provide a more optimal fit.
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Depth Gauge
measurement: 14mm
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Trial selection
Using the depth measurement determined by the gauge, select an
available width and height to choose a Trial. Reference the table on the
next page for depth, width, and height combinations. Trialing should
begin with:
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A
conservative height not to exceed the height
of healthy adjacent discs.* |
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A width
that should extend to the uncinate
processes, but should not ride up onto
either uncus. |
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A depth
that leaves 1mm of space from the anterior
and posterior vertebral borders. The Trial
should not protrude past the edge of the
vertebrae. |
The ROI-C Trials:
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Should
provide optimal endplate coverage, height
restoration, and good stability. |
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Have the
same dimensions as the implants. |
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Are color
coded by footprint size to match the implant
packaging’s color dot on the side of the
box. |
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Implant reference table
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Trial positioning
Place the Trial
in front of the space to visually determine width.
Insert the selected Trial into the space. Under
lateral radiographic imaging confirm the:
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Implant depth and height |
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Endplate
coverage (anterior-posterior) |
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Conformity
with the superior dome. |
Release the distraction in order to assess the height
that will best restore anatomic shape of the
operated space, as well as the best stability to the
implant.*
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*Note: Without distraction, the
Trial should be snug in the disc space even as
the Trial’s integrated handle is gently pulled
away directly anterior from the vertebrae to
assess fit.
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Final size selection
Repeat the trialing process
until satisfied with the
footprint and height.*
It is
very important that the Trial
has good contact with the
inferior and superior endplates
via proper height selection.
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*Note: Radiographic
imaging is mandatory to
confirm sizing. The hole
through the Trial should
appear circular. An oval
shape indicates possible
rotation.
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Implant insertion
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Step 3
 Depth stop selection
The ROI-C system offers two depth stops: the standard adjustable
depth stop and the ROI-C Adjustable Stop (MC9004R) with a larger
footprint.
The larger footprint depth stop can be used with sclerotic bone where
the force required to seat the plates may be greater. The larger depth
stop can also serve as a gauge for assessing Caspar Pin placement. If
the Caspar Pin sits above the larger depth stop, there will be adequate
clearance for the plate to completely seat in the PEEK without risk of
hitting the pin.
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 Holder components
Detach the knurled thumb wheel (B) from the end of the
selected depth stop (A), which for shipping purposes comes
assembled in the tray.
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 Depth stop assembly
Load the knurled thumb wheel into the pocket on the body of
the Implant Holder (C).
Slide the selected depth stop through the distal tip of the
Implant Holder and into the knurled wheel. Secure the depth
stop by rotating the thumb wheel in a clockwise direction.
Setting the length of the depth stop or Adjustable Stop is
discussed further on page 10.
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 Threaded rod assembly
Load the threaded rod (D) in the handle and down the shaft
of the Implant Holder; rotate the knurled knob clockwise to
secure.
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Implant connection to Holder
Connect the selected implant to the Implant Holder
by engaging the hook on the Holder with the slot
on the side of the implant.
Once the hook is engaged, fully screw the knob on
the end of the Holder to secure the implant with
the threaded rod.
It is critical to firmly secure the implant to the
Holder.
The connection is secure when after finger
tightening:*
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There
should be no toggle in the connection. |
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There should be no gap visible between
the knob and the handle. |
*Note: Over tightening could strip the PEEK threads and
weaken the implant to Holder connection.
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 Bone graft loading
Load the central space of the implant with autologous bone.
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Implant insertion
The Adjustable Stop is
designed to ensure proper
location and fixation of the
plates into the vertebrae. Set
the Adjustable Stop on the
Implant Holder to 0mm. When the
depth stop is set to 0mm, the
implant will be recessed by 1mm
into the disc space.
Insert implant by gently tapping the end of the
Implant Holder as necessary to insert the
implant. Try to keep the Implant Holder at a 90°
angle to the disc space.
If the implant position is too anterior, the AP
positioning can be adjusted by dialing the
Adjustable Stop from 0-5mm. For each millimeter
the depth stop advances, the implant moves 1mm
posterior.
Under radiographic imaging, complete the
insertion of the implant and do a final
assessment of implant depth and endplate
coverage, prior to plate insertion.
A tantalum marker is located 1mm from the
posterior implant edge for positioning reference.
Verify the marker is at least 1 or 2mm anterior
to the canal to avoid dura mater compression.
CAUTION: Radiographic imaging is mandatory prior
to plate insertion.
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Plate insertion
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Step 4
 Plate selection
Select the plate length according to implant height. Use the ROI-C Standard
Plate (MC1005T) with heights 4.5-7mm and the ROI-C Long Plate (MC1006T)
with 8mm high implants.
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Plate reference table
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Remove distractor
Remove the distractor and Caspar Pins if used, to allow compression
of the construct.*
Load first plate
With the implant in the optimal position, load the first plate into the
cranial slot of the Implant Holder using the Plate Holder (MC901R).
As the plate paths cross within the Implant Holder, the plate inserted
into the cranial slot will be advanced into the caudal vertebral body.
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*Note: The Implant
Holder must be left
attached to the implant
during placement of the
plates. |
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Advance first plate
Confirm implant is still securely attached to the holder.
Using thumb pressure, insert the ROI-C Initial Impactor (MC9002R)
to advance the first plate until it touches bone.* Take a lateral
radiographic image to verify the plate is touching the bone. Then use
a mallet to finish the first plate’s insertion into the bone. Confirm the
mechanical stop on the impactor meets the mechanical stop on the
plate housing portion of the Implant Holder.
 *Note: If the plate does not advance with thumb pressure, confirm the plate is properly
loaded in the Holder and the Holder is aligned with the PEEK.
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 Verify first plate position
Take a lateral radiographic image to ensure proper implant and plate position
and stability.
Do not proceed to lock the first plate until proper placement of the device and
first plate is confirmed via fluoroscopy or x-ray. |
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Lock first plate
Once position is confirmed, use the ROI-C Final
Impactor (MC9003R) to lock the first plate in place.
Again, the plate will have advanced completely
when the mechanical stop on the Final Impactor
meets the mechanical stop on the Implant Holder.*
Verify first plate final position
After final lock, take a lateral radiographic image
to ensure proper implant and plate position, and
overall stability.
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*Note: To ensure proper lock, the plates must be
advanced and locked using this impactor sequence:
1st Plate:
• Advance with thumb
pressure
• Initial Impactor
• Final Impactor
2nd Plate:
• Advance with thumb
pressure
• Initial Impactor
• Final Impactor
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Load second plate
Confirm knob on end of Implant Holder is fully tightened. Insert the second
plate into the caudal slot of the Implant Holder.
The plates must be inserted one after the other, as the plate paths cross in the
plate housing portion of the Implant Holder. The second plate can only be
inserted after the first plate is locked.
Advance and lock second plate
Using the same technique as the first plate, with thumb pressure insert the
ROI-C Initial Impactor to advance the second plate until it touches bone. Then
use a mallet to finish the second plate’s insertion into the bone and to the
mechanical stops.
Confirm position under radiographic imaging and then final lock the plate
using the ROI-C Final Impactor. The placement of both plates locks and secures
the implant in place.
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Implant Holder removal and final assessment
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Step 5
 Implant Holder removal
Remove the Implant Holder by turning the knob on the end of the
Holder counter-clockwise until the threads disengage. Then slide
the Holder to the left releasing the hook from the slot in the implant
before removing the Holder.
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Final fluoroscopy or x-ray of proper placement*
Confirm proper placement with radiographic imaging.
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*Note: In cases of vertebral instability or
significant bone removal the ROI-C implant with
VerteBRIDGE plating should be augmented
with anterior plating and/or posterior pedicle screws.
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Device description and use guidelines
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Device description
The ROI-C Implant System consists of roughly rectangular shaped blocks in a variety of footprints and heights. The shape of the ROI-C allows
for a large implant (length and width) to be used allowing for more surface area contact. The ROI-C is offered in a closed graft space design.
The implants feature an enclosed chamber intended to be filled with autologous bone graft. The superior and inferior surfaces of the implants
have a pattern of teeth to provide increased stability and to help prevent movement of the device. The ROI-C is intended to be implanted
singularly via an anterior approach. The devices must be used with supplemental internal fixation.
NOTE: The ROI-C has been designed to be compatible with optional supplemental fixation specific for the system. The VerteBRIDGE® Plates are
available and may be used to affix the ROI-C implants to the underlying vertebral bone and to specifically allow for the option of a stand-alone
construct. Additional or other supplemental fixation may be used, as patient needs dictate.
The materials used in the manufacturing of the ROI-C implants are (radiolucent) PEEK Optima® LT 1 and tantalum alloy radiological position
markers. The ROI-C VerteBRIDGE Plates are manufactured from surgical titanium (Ti6A14V), which complies with ASTM F136. Instruments used
to implant ROI-C are made of medical grade stainless steel. |
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Contraindications
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Presence of fever or acute,
chronic, systemic, or localized infection. |
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Metal sensitivity or
allergies to the implant materials,
documented or suspected. |
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Severe osteopenia. |
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Pregnancy. |
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Prior fusion at the
level(s) to be treated. |
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Patients unwilling or
unable to follow post-operative care
instructions. |
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Other medical risks,
anesthetics risks, or surgical conditions
which would preclude the potential benefit
of spinal implant surgery |
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Any condition not described
in the indications for use. |
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Precautions
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Being a technically
demanding procedure presenting a risk of
serious injury to the patient, the
implantation of intervertebral body fusion
devices or partial vertebral body
replacement devices should be performed only
by experienced spine surgeons with specific
training in the use of this system and who
have knowledge of the present instructions
for use. |
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The surgeon should consider
the location of implantation, the weight of
the patient, the patient’s activity level or
general conditions, and any other factor
which may have an impact on the performance
of the system. |
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Patients who smoke have
been shown to have an increased risk of
non-unions. Such patients should be advised
of this fact and warned of the potential
consequences. |
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If the patient is involved
in an occupation or activity which applies
inordinate stress upon the implant (e.g.,
substantial walking, running, lifting of
significant loads, or muscle strain),
resultant forces can cause failure of the
device. |
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In some cases, progression
of degenerative disease may also be so
advanced at the time of implantation that
they may substantially decrease the expected
useful life to the device. In such cases,
orthopedic devices may be considered only as
a delaying technique or to provide temporary
relief. |
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Before clinical use, the
surgeon should thoroughly understand all
aspects of the surgical procedure and
limitations of the system. This device is
recommended for use only by surgeons
familiar with preoperative and surgical
techniques, cautions and potential risks
associated with such spinal surgery.
Knowledge of surgical techniques, proper
reduction, selection and placement of
implants, and pre- and post-operative
patient management are considerations
essential to a successful surgical outcome.
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Patients should be
instructed in detail about the limitations
of the implants, including but not limited
to the impact of excessive loading through
patient weight or activity, and should be
taught to govern their activities
accordingly. |
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Appropriate selection,
placement and fixation of the spinal system
components are critical factors which affect
implant service life. Accordingly, strict
adherence to the indications,
contraindications, precautions, and warnings
for this product is essential to potentially
maximize service life. (Note: While proper
implant selection can minimize risks, the
size and shape of human bones present
limitations on the size, shape, and strength
of implants.) |
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Supplemental internal
fixation is required when using the ROI-C
System. The VerteBRIDGE Plate system is
available for use with ROI-C, and is the
supplemental fixation available for use in
situations where a stand-alone construct is
appropriate. The system may be augmented
with additional supplemental fixation, as
needed and determined by the user. The
instructions for use for any additional
supplemental fixation system(s) should be
followed according to the manufacturer’s
guidelines. |
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Care must be taken to
protect the components from being marred,
nicked, or notched as a result of a contact
with metal or abrasive objects. Alterations
will produce defects in surface finish and
internal stresses which may become the focal
point for eventual breakage of the implant.
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Inspection and trial
assembly are recommended prior to surgery to
determine if the instruments have been
damaged during storage or prior procedures.
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Sale of this product is
restricted to physicians. |
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Warnings
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Risks associated with
general surgery, orthopedic surgery, and the
use of general anesthesia should be
explained to the patient prior to surgery.
It is also recommended that the
advantages and disadvantages of surgery, the
implants, as well as alternative treatment
methods be explained to the patient. |
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Potential risks associated with the use of this system, which may require additional surgery, include device component failure (bending, loosening
or fracture), loss of fixation, non-union, fracture of the vertebra, neurological injury, vascular or visceral injury, neurological complications, overdistraction,
trauma to nerve root or dura, incorrect implant positioning, implant migration, pseudoarthrosis, disc height loss (impaction of implant
into vertebral endplates), allergy or inflammation, general adverse effects related to surgical procedures (e.g. anesthesia, infection), subsidence, or
expulsion. |
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The device can break if it is subjected to increased loading associated with delayed union or non-union. If healing is delayed or does not occur, the
implant could eventually break due to material fatigue. Factors such as the patient weight, activity level, and compliance to weight bearing or load
bearing instructions, have an effect in the stresses to which the implant may be subjected, and may effect the longevity of the implant. |
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Patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without a previous surgery. |
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Discard all damaged or mishandled implants. |
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Under no circumstances may the implants be re-used. Although the device may appear intact on removal, internal modification due to the stress and
strains placed on it or small defects may exist which may lead to fracture of the implant. |
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Implants removed from a patient that contact bodily tissues or fluids should never be reused at risk of contamination of the patient. |
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Mixing Metal: Some degree of corrosion occurs on all implanted metal and alloys. Contact of dissimilar metals (e.g. stainless steels and titanium),
however, may accelerate this corrosion process. The presence of corrosion may accelerate fatigue fracture of implants and the amount of metal
compounds released into the body system may also increase. Internal fixation devices such as rods, connectors, screws, hooks, etc, which come into
contact with other metal objects must be made from like or compatible metals. This is an important consideration when using supplemental fixation,
as required by the indications for use of the System. |
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Because different manufacturers employ different materials, varying tolerances, manufacturing specifications, and differing design parameters,
components of the ROI-C Implant System should not be used in conjunction with components from any other manufacturer’s implant systems. Any
such use will negate the responsibility of LDR Spine USA for the performance of the resulting mixed component implant. |
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Any decision by a surgeon to remove the implanted device should take into consideration such factors as the risk to the patient of the additional
surgical procedure as well as the difficulty of removal. |
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Implant removal should be followed by adequate postoperative management to avoid fracture. |
REF: IR-C ST 1 EN 08.2011 C US
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