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OPERATIVE TECHNIQUE
JANUS®
MIDLINE FIXATION SCREW
FIREBIRD® SPINAL FIXATION SYSTEM
phoenix® minimally invasive spinal fixation system
TA BL E OF CON T E N T S
Introduction3
Operative Technique
4
Instruments19
Implants20
Indications for Use
21
The surgical technique shown is for illustrative purposes only.
The technique(s) actually employed in each case will
always depend upon the medical judgment of the surgeon
exercised before and during surgery as to the best mode
of treatment for each patient. Please see Instructions
for Use for the complete list of indications, warnings,
precautions, and other important medical information.
INTRODUCTION
INTRODUCTION
As an addition to the Firebird® Spinal Fixation System, the
JANUS® Midline Fixation Screw from Orthofix provides
surgeons with the option of a midline approach.
The JANUS Midline Fixation Screw is designed to achieve
more cortical bone purchase in the medial to lateral
trajectory when compared to traditional pedicle screws.
With its modular screw design, maximized visualization is
possible when working in a smaller midline incision
or minimally invasive surgical approach.
JANUS Midline Fixation Screw is available in both
non-cannulated and cannulated versions.
Non-Cannulated
Cannulated
3
4
OPERATIVE TECHNIQUE
Fig. 1
Fig. 2
1. ACCESS
2. IDENTIFICATION OF ENTRY POINT
A posterior midline incision is made followed by a
standard posterior midline approach and placement
of common retractors to maintain exposure. The
approach is extended to identify the lateral border
of the facet and the lateral edge of the pars. In
cephalad caudal direction the exposure is to the mid
facet for the cephalad level and to the mid-lamina
for the caudal level. (Fig. 1)
Proper entry point for the JANUS Midline Fixation
Screw is at the inferior border of the transverse
process and about 3mm to 5mm medial to the
lateral edge of the pars (approximately the midpoint
of the inferior facet of the level above). This position
allows the starting point to be superior to the
neuroforamen. Obtain an AP image to confirm the
entry point is the medial border of the pedicle at
a 7 o’clock position for the right pedicle, and a 5
o’clock position for the left pedicle. (Fig. 2)
NOTE: When using the JANUS cannulated screw in
an MIS procedure, refer to to the Phoenix Minimally
Invasive Spinal Fixation System Operative Technique.
Fig. 2
OPERATIVE TECHNIQUE
Fig. 3a
Fig. 3b
TRAJECTORY FOR CORTICAL
CANCELLOUS SCREW PLACEMENT
3. SCREW STARTING POINTS
Move the C-arm to a lateral position, aim and
advance the bone probe to the posterior 1/3 or
mid portion of the superior endplate, while aiming
approximately 15-20 degrees medial to lateral. The
result is an acute trajectory above the neuroforamen
and positioned away from the central canal and
the exiting nerve root. Note that the sagittal plane
inclination of the probe should be at the greatest
angle in the caudal-to-cephalad direction.
Use modular screws for the midline approach
indicated by the red lines. (Figs. 3a and 3b)
5
6
OPERATIVE TECHNIQUE
Fig. 4
Fig. 5
4. BONE AWL
5. BONE PROBE
(52-1001) Penetrate the cortex of the bone with the
bone awl to create a pilot hole at the entry point.
(Fig. 4)
(52-1002 / 52-1003) Aim for the posterior 1/3 or
mid portion of the superior endplate in the sagittal
plane, while aiming approximately 15-20 degrees
medial to lateral. (Fig. 5 )
OPERATIVE TECHNIQUE
Fig. 6
Fig. 7
6. DRILLING
7. SOUNDER
(36-1124 / 36-1125 / 36-1126 / 36-1127)
(52-1004 Small / 52-1005 Large) Use the sounder
to confirm the existence of bone along the walls
of the screw trajectory. Choose the appropriate tip
and internally palpate to ensure the walls are not
perforated. (Fig. 7)
Use the drill that corresponds to the selected bone
screw diameter. The proximal end of the drill shaft has
a colored band that corresponds to the diameter of
the screw. Use the A/O quick connect feature on the
drill to connect the Modular Handle (69-1030). Insert
the drill into the Drill Guide (36-1012). Prior to start
of drilling, ensure that the tip of the Drill is in the pilot
hole created by the Awl. The drill should be advanced
slowly and controlled while using irrigation to prevent
bone injury. Aim for the posterior 1/3 or mid portion
of the superior endplate in the sagittal plane, while
aiming approximately 15-20 degrees medial to lateral.
The endplate should not be breached. The drill is
capable of drilling 28.5mm deep holes. (Fig. 6)
Diameter
Screw Color
Drill Color
Tap Color
4.5mm Silver
Silver
Silver
5.5mm Green
Green
Green
6.5mm Gold
Gold
Gold
7.5mm Blue
Blue
Blue
7
8
OPERATIVE TECHNIQUE
Fig. 8
Fig. 9
8. X-RAY MARKERS
9. SCREW SIZING TEMPLATE
(55-1006 Right / 52-1007 Left) Use the right and
left x-ray markers to confirm trajectory under
fluoroscopy prior to screw insertion. (Fig. 8)
Use the Screw Sizing Template (52-1308) to verify
screw diameter and length of the JANUS Midline
Fixation Screw prior to insertion. (Fig. 9)
OPERATIVE TECHNIQUE
Fig. 10
10. TAP
Tap the pilot hole with the same size bone tap as
the final screw diameter and advance to the superior
endplate. Tap to the appropriate depth based on the
length of the JANUS Midline Fixation Screw to be
implanted for optimal screw purchase, using the 5
millimeter increment markings on the tap as a guide.
Do not violate the endplate.
Select the Bone Tap (36-XXXX) that matches the
bone screw diameter that will be used. The Bone
Tap dimensions are line to line (one to one) with
the bone screw dimensions. The bone tap only
includes the bone screw cancellous thread form. Use
Bone Tap (36-) to tap the pilot hole and continue
advancing the bone tap to endplate of the vertebral
body. Use the 5mm markings along the length of
the bone tap shaft to determine how deep the tip
of the bone tap is advancing. (Fig. 10)
NOTE: Tapping is required prior to inserting a
JANUS Midline Fixation Screw, the optional JANUS
Cortical Bone Tap (36-XXXX) must be used. Firebird
and Phoenix® Taps are designed with a different
thread pitch. To reduce the risk of screw pullout,
it is not recommended to use a Firebird or Phoenix
Tap to prepare the hole for a JANUS Midline Fixation
Screw insertion.
NOTE: To attach the Ratcheting Handle, T-Handle 52-1011) or
Ratcheting Handle Straight, Small (52-1013) to the modular taps,
retract the shaft connector sleeve and insert the square-drive
shaft end of tap into the handle connector, and release shaft
connector sleeve. To disengage the tap from the handle, retract
the shaft connector sleeve and firmly tug on the instrument shaft.
NOTE: Ensure that the Tap is fully inserted and seated inside the
Straight or Ratcheting T-handle, prior to the application of torque.
Inadequate seating may create a binding condition with the handle, after torque is applied. Proper connection of the shaft with
the handle can be confirmed by gently tugging on the shaft
9
10
OPERATIVE TECHNIQUE
Fig. 11
11. SCREW INSERTION
Midline Screw Driver (36-1834) Insert the self-retaining
driver completely into the JANUS screw.
Insert the JANUS screw until it is positioned at the
posterior 1/3 or mid portion of the superior endplate.
The screw should not perforate the endplate. The
spherical screw head should be left slightly proud
to avoid damage to the facet joint. To disengage
the Midline Screw driver, lift the screw driver until it
separates from the JANUS screw.
NOTE: Do not apply levering force to driver during
screw insertion as this can result in missed trajectory
of screw or vertebral fractures.
NOTE: If the screw insertion site is not prepared by
drilling and tapping, there is an increased chance of
toggle between the bone screw and the Modular
Screw Driver (36-1834) that could affect bone
screw trajectory.
Fig. 12
12. DECORTICATION
Decorticating Planer (52-1334)
After placement of the modular JANUS Midline
Fixation Screw, place the decorticating planer over the
spherical head of the bone screw. Rotate the planer
surface clockwise and counterclockwise to decorticate
bone and allow for proper seating of modular body
providing full range of motion. (Fig. 12)
OPERATIVE TECHNIQUE
Fig. 13
Fig. 14
13. SCREW BODY OPTIONS
14. MODULAR BODY ATTACHMENT
Top-Loading (44-2101) Insert the rod from a top
orientation prior to securing with set screw.
After placement of the modular JANUS Midline
Fixation Screw, attach the appropriate modular body
to the Holder (51-7100) by aligning the pin holes on
body with inserter and clamp. Slide the body onto
the bone screw by applying an axial force to connect
the base of the body to the spherical head of the
JANUS Midline Fixation Screw. The pressure cap will
move freely in the body to allow for proper insertion.
Reduction (44-2103) Insert the rod from a top
orientation prior to securing with set screw. Break
off tabs after set screw is below the line of the
extended tabs. (Fig. 13)
Confirm a secure connection between the body and
bone screw by pulling up on the holder prior to
disconnecting. When the body remains attached to
the bone screw, the assembly is secure. (Fig. 14)
11
12
OPERATIVE TECHNIQUE
Fig. 15
Fig. 16
15. BODY ALIGNMENT
16. ADJUSTMENT DRIVER
Head Adjuster (52-1038) Use the head adjuster
to align the top opening bodies of the multi-axial
screw prior to rod insertion.
Multi-Axial Adjustment Driver (52-1339) Use the
multi-axial adjustment driver to adjust the sagittal
height of the screws prior to rod insertion. (Fig. 16)
NOTE: This instrument can assist in restoring
mobility of the multi-axial bodies if screw has been
driven too deep. (Fig. 16)
OPERATIVE TECHNIQUE
Fig. 17
Fig. 18
17. ROD PREPARATION
18. ROD CUTTING
Rod Template
Pin Cutter (55-1041) Once the correct length is
established, use the rod cutter to cut rod to the
desired length referencing the rod template as a
guide. (Fig. 18)
Determine the rod contour and length required
using the trial rod (52-1040 thru 52-1042).
Rod Selection
NOTE: When there is need for a stiffer rod, Cobalt
Chrome rods may be used as an alternative to
Titanium rods.
NOTE: Both rod materials are compatible with
standard Titanium Firebird Spinal Fixation System
implants. (Fig. 17)
13
14
OPERATIVE TECHNIQUE
Fig. 19
Fig. 20
19. ROD CONTOURING
20. ROD INSERTION
Rod Bender (52-1046) Utilizing the rod bender,
create the correct contour, referencing the rod
template as a guide. See step 17 for determining
rod length.
Rod Inserter (52-1581) Orient the screws so that
the screw bodies are in the longitudinal plane. Once
positioning is achieved, use the rod inserter to place
the rod in the screw bodies.
WARNING: The rods should not be repeatedly or
excessively bent any more than absolutely necessary.
The rods should not be reverse bent in the same
location. (Fig. 19)
NOTE: Avoid applying unnecessary lateral bending
or rotational force to rod inserter.
NOTE: Ensure the rod seating area is clear of any
bony/tissue interferences before attempting to reduce the rod. (Fig. 20)
OPERATIVE TECHNIQUE
Fig. 21
Fig. 22a
21. ROD ROCKER
22A. ROD PUSHER
Rod Rocker (52-1251) Attach rocker to screw body
and lever rod until seated in the screw.
Rod Pusher (52-1050) Position rod pusher tip on
rod and apply axial force until rod is seated in screw
NOTE: Unnecessary lateral bending or excess
rotational force may cause reducer to slip from
screw head during reduction or the inability to
properly insert set screw.
NOTE: Applying too much reduction force to screws
can result in screw pullout. (Fig. 21)
body. (Fig. 22a)
15
16
OPERATIVE TECHNIQUE
Fig. 22b
Fig. 23
22B. ROD REDUCER
23. FINAL TIGHTENING
Rod Reducer (52-1755) Slide rod reducer tip over
the screw body and seat pins into indents. Take
care to align inner shaft with rod prior to reduction.
(Fig. 22b)
Counter Torque Wrench (52-1765) Set Screw Driver
(52-1061) Torque Limiting Handle (52-1512)
Position the counter torque wrench over the screw
and rod making sure to engage tips to align rod
within screw body. Place the set screw driver
through the cannulation of the counter torque
wrench and into the hex of the set screw. Turn the
torque limiting handle clockwise and apply counter
torque with the counter torque wrench to tighten
the set screw to 100 in-lbs. The torque limiting
handle will reach its maximum torque and release
at 100 in-lbs.
NOTE: Insert the set screw driver into the torque
limiting handle by compressing connection
mechanism. Ratcheting feature will not function
properly unless driver is fully seated before releasing
connection mechanism. Ensure the ratcheting dial is
set to forward “F” prior to engaging the set screw.
(Fig. 23)
OPERATIVE TECHNIQUE
Fig. 24
24. REMOVAL
Set Screw Driver (52-1061) Counter Torque Wrench
(52-1765) Multi-Axial Adjustment Driver (52-1339)
In order to remove the JANUS Midline Fixation
Screw, fully seat the set screw driver securely into
the set screw and turn counter clockwise to loosen
the set screw. Use of counter torque wrench is
recommended to avoid damage to the pedicle.
Carefully remove all set screws. The multi-axial
adjustment driver can be utilized to remove the
screw assemblies. The multi-axial adjustment driver
must be used to remove bone screws that are
attached to offset heads. (Fig. 24)
17
18
INSTRUMENTS AND IMPLANTS
Instruments and Implants
IMPORTANT ORDERING INFORMATION: the instrument case
and JANUS screw caddies have individual product numbers and must be
ordered at the same time. The JANUS cannulated and non-cannulated
screw caddies are not included in the instrument case during shipment.
The JANUS screw caddies should be placed inside the instrument case for
the procedure, cleaning and sterilzation.
INSTRUMENTS
INSTRUMENTS
Drills
Part #
Description
36-11244.5mm
36-11255.5mm
36-11266.5mm
36-11277.5mm
Non-cannulated Cortical Bone Tap, Modular)
Part #
Description
36-12244.5mm
36-12255.5mm
36-12266.5mm
36-12277.5mm
Cannulated Cortical Bone Tap, Modular)
Part #
Description
36-14244.5mm
36-14255.5mm
36-14266.5mm
36-14277.5mm
Handle)
Part #
Description
69-1030
Modular Handle
Part #
Description
36-1012
Drill Guide
36-1834
Midline Screw Driver
Drill
Guide
Handle
)
36-7200Instruments
Top Level
Bottom Level
19
20
IMPLANTS
IMPLANTS
36-9100 Non-Cannulated Implant Caddy
Part #
Description
36-2425
36-2430
36-2435
36-2440
36-2445
36-2525
36-2530
36-2535
36-2540
36-2545
36-2625
36-2630
36-2635
36-2640
36-2645
4.5mm x 25mm
4.5mm x 30mm
4.5mm x 35mm
4.5mm x 40mm
4.5mm x 45mm
5.5mm x 25mm
5.5mm x 30mm
5.5mm x 35mm
5.5mm x 40mm
5.5mm x 45mm
6.5mm x 25mm
6.5mm x 30mm
6.5mm x 35mm
6.5mm x 40mm
6.5mm x 45mm
Qty Availability
6
6
6
6
6
6
6
6
6
6
4
4
4
4
4
Standard
Standard
Standard
Standard
Standard
Standard
Standard
Standard
Standard
Standard
Standard
Standard
Standard
Standard
Standard
36-9200 Cannulated Implant Caddy
Part #
36-3425
36-3430
36-3435
36-3440
36-3445
36-3525
36-3530
36-3535
36-3540
36-3545
36-3625
36-3630
36-3635
36-3640
36-3645
Description
4.5mm x 25mm
4.5mm x 30mm
4.5mm x 35mm
4.5mm x 40mm
4.5mm x 45mm
5.5mm x 25mm
5.5mm x 30mm
5.5mm x 35mm
5.5mm x 40mm
5.5mm x 45mm
6.5mm x 25mm
6.5mm x 30mm
6.5mm x 35mm
6.5mm x 40mm
6.5mm x 45mm
Qty Availability
6
Standard
6
Standard
6
Standard
6
Standard
6
Standard
6
Standard
6
Standard
6
Standard
6
Standard
6
Standard
4
Standard
4
Standard
4
Standard
4
Standard
4
Standard
Optional Non-Cannulated Implants
Part #
36-2450
36-2455
36-2460
36-2465
36-2550
36-2555
36-2560
36-2565
36-2650
36-2655
36-2660
36-2665
36-2725
36-2730
36-2735
36-2740
36-2745
36-2750
36-2755
36-2760
36-2765
Description
4.5mm x 50mm
4.5mm x 55mm
4.5mm x 60mm
4.5mm x 65mm
5.5mm x 50mm
5.5mm x 55mm
5.5mm x 60mm
5.5mm x 65mm
6.5mm x 50mm
6.5mm x 55mm
6.5mm x 60mm
6.5mm x 65mm
7.5mm x 25mm
7.5mm x 30mm
7.5mm x 35mm
7.5mm x 40mm
7.5mm x 45mm
7.5mm x 50mm
7.5mm x 55mm
7.5mm x 60mm
7.5mm x 65mm
Availability
By request
By request
By request
By request
By request
By request
By request
By request
By request
By request
By request
By request
By request
By request
By request
By request
By request
By request
By request
By request
By request
Optional Cannulated Implants
Part #
36-3450
36-3455
36-3460
36-3465
36-3550
36-3555
36-3560
36-3565
36-3650
36-3655
36-3660
36-3665
36-3725
36-3730
36-3735
36-3740
36-3745
36-3750
36-3755
36-3760
36-3765
Description
4.5mm x 50mm
4.5mm x 55mm
4.5mm x 60mm
4.5mm x 65mm
5.5mm x 50mm
5.5mm x 55mm
5.5mm x 60mm
5.5mm x 65mm
6.5mm x 50mm
6.5mm x 55mm
6.5mm x 60mm
6.5mm x 65mm
7.5mm x 25mm
7.5mm x 30mm
7.5mm x 35mm
7.5mm x 40mm
7.5mm x 45mm
7.5mm x 50mm
7.5mm x 55mm
7.5mm x 60mm
7.5mm x 65mm
Availability
By request
By request
By request
By request
By request
By request
By request
By request
By request
By request
By request
By request
By request
By request
By request
By request
By request
By request
By request
By request
By request
INDICATIONS FOR USE
Description: The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are temporary, multiple component systems comprised of a variety of non-sterile
and sterile, single use components, made of titanium alloy or cobalt chrome alloy, that allow the surgeon to build a spinal implant construct. The systems are attached to the
vertebral body and ilium by means of screw or hook fixation to the non-cervical spine. The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System consist of an
assortment of rods, multi-axial and mono-axial pedicle screws, set screws, lateral offsets, bone screws, screw bodies, hooks, iliac connectors and STERILE packed HA Coated
bone screws. A subset of the Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System components may be used in pediatric patients. These components consist
of a variety of screws ranging in diameters from 4.0mm to 7.5mm and lengths ranging from 25mm to 60mm. The Firebird Spinal Fixation System and Phoenix MIS Spinal
Fixation System implants are not compatible with components or metal from any other manufacturer’s system.
Indications for Use: The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are intended for posterior, non-cervical pedicle, and non-pedicle fixation
(T1-S2/Ilium). Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated
for all of the following indications:
a) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
b) spondylolisthesis,
c) trauma (i.e., fracture or dislocation),
d) spinal stenosis,
e) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
f) tumor,
g) pseudoarthrosis, and
h) failed previous fusion
When used for fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws planced at the S1 or S2
spinal level.
The Phoenix MIS Spinal Fixation System when used with the Firebird Spinal Fixation System is indicated to provide the surgeon with a minimally invasive approach for posterior
spinal surgery.
The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System components are used with certain components of the Orthofix Spinal Fixation System, including
rods, rod connectors and cross-connectors.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation System implants are indicated as an adjunct to fusion to treat
adolescent idiopathic scoliosis. The Firebird Spinal Fixation System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is
limited to a posterior approach.
Contraindications include, but are not limited to:
1. Morbid obesity
2. Mental Illness
3. Alcoholism or drug abuse
4. Pregnancy
5. Metal sensitivity/allergies
6. Severe osteopenia
7. Patients unwilling or unable to follow post-operative care instructions
8. Use of the Firebird offset connectors for fixation to the ilium is contraindicated when the sacrum is absent or insufficient for implantation of pedicle screws at the S1
or S2 spinal level.
9. Any circumstances not listed under the heading indications.
Potential Adverse Events:
All of the possible adverse events associated with spinal fusion surgery without instrumentation are possible. With instrumentation, a listing of possible adverse events includes,
but is not limited to:
1. Inability to use pedicle screw fixation due to anatomic limitations (pedicle dimensions, distorted anatomy)
2. Pedicle screw mal positioning, with or without neurological or vascular injury
3. Proximal or distal junctional kyphosis
4. Pancreatitis
5. Pedicle screw fixation, such as screw or rod bending, breakage, or loosening, may also occur in pediatric patients, and pediatric patients, and pediatric patients may be at
increased risk for device-related injury because of their smaller stature.
6. Device component fracture
7. Loss of fixation
8. Non-union
9. Fracture of the vertebra
10. Neurological injury
11. Vascular or visceral injury
12. Early or late loosening of any or all of the components
13. Disassembly and/or bending of any or all components
14 Foreign body (allergic) reaction to implants, debris, corrosion products, graft material, including metallosis, straining, tumor formation, and/or auto-immune disease
15. Pressure on the skin from component parts in patients with inadequate tissue coverage over the implant possibly causing skin penetration, irritation, and/or pain
16. Post-operative change in spinal curvature, loss of correction, height, and/or reduction
17. Infection
18. Pain, discomfort, or abnormal sensations due to the presence of the device
19. Hemorrhage
20. Cessation of any potential growth of the operated portion of the spine
21. Death
Note: Potential risks identified with the use of the device system may require additional surgery.
21
22
INDICATIONS FOR USE
Warnings and Precautions:
1. The safety and effectiveness of this device has not been established for use as part of a growing rod construct. This device is only intended to be used when definitive
fusion is being performed at all instrumented levels.
2. The use of pedicle screw fixation in the pediatric population may present additional risks when patients are of smaller stature and skeletally immature. Pediatric patients
may have smaller spinal structures (pedicle diameter or length) that may preclude the use of pedicle screws or increase the risk of pedicle screw mal positioning and
neurological or vascular injury. Patients who are not skeletally mature undergoing spinal fusion procedures may have reduced longitudinal spinal growth, or may be at
risk for rotational spinal deformities (the “crankshaft phenomenon”) due to continued differential growth of the anterior spine.
3. The implantation of pedicle screw spinal systems in pediatric patients should be performed only by experienced spinal surgeons with specific training in the use of this
pedicle screw spinal system in pediatric patients because this is a technically demanding procedure presenting a risk of serious injury to the patient.
4. Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and proper selection of placement of the implants are important
considerations in the successful utilization of the system in pediatric patients.
5. The selection of proper size, shape and design of the implant for each patient is crucial to the safe use of this device in pediatric patients.
6. The safety and effectiveness of pedicle screw systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion
with instrumentation. These conditions are: significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis
(grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal
tumor, and failed previous fusion (pseudoarthrosis). The safety and effectiveness of these devices for any other condition are unknown.
7. Benefit of spinal fusions utilizing any pedicle screw fixation system has not been adequately established in patients with stable spines.
8. Potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of fixation, non-union, fracture
of the vertebra, neurological injury, and vascular or visceral injury.
9. Single use only
10. Non-sterile; the screws, hooks, rods, dominos, lateral offsets, spacers, staples, washers, locking nuts, cross connectors, and instruments are sold non-sterile, and
therefore must be sterilized before use.
11. To facilitate fusion, a sufficient quantity of autologous bone or other appropriate material should be used.
12. Failure to achieve arthrodesis will result in eventual loosening and failure of the device construct.
13. Excessive torque applied to the screws may strip the threads in the bone.
14. DO NOT REUSE IMPLANTS. Discard used, damaged, or otherwise suspect implants.
15. The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal
system because this is a technically demanding procedure presenting a risk of serious injury to the patient.
16. Based on fatigue testing results, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc.
which may impact on the performance of the system.
17. Mixing of dissimilar metals can accelerate the corrosion process. Do not use the titanium alloy or cobalt chrome alloy components of this system with implants of other
material composition or components from different manufacturers unless specifically stated.
18. The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System have not been evaluated for safety and compatibility in the MR environment, nor have the
Firebird Spinal Fixation System or the Phoenix MIS Spinal Fixation System been tested for heating or migration in the MR environment.
19. Reuse of the devices labeled as single-use could result in injury or re-operation due to breakage or infection. Do not attempt to re-sterilize single-use implants that
come in contact with body fluids.
20. When using the offset connectors to connect the Firebird spinal construct to the ilium, pedicle screws must be used at the S1 or S2 level of the spine. Do not use the
offset connectors to connect the ilium without this intermediate screw fixation.
21. The safety, efficacy and performance of the system have been established for conditions in which the system is used as intended and when used as identified in the
Indications for Use. Performance of the system has not been evaluated for use that is contrary to the Intended Use, Indications for Use or for use that in contraindicated.
Failure to use the system as indicated could detrimentally affect the performance of its components.
22. Other adverse effects related to pedicle screw fixation, such as screw or rod bending, breakage, or loosening, may also occur in pediatric patients. Pediatric patients
may be at increased risk for device-related injury because of their smaller stature.
23. The correct handling of the implant is extremely important. Implants should not be excessively or repeatedly bent, notched or scratched. These operations can produce
defects in surface finish and internal stress concentrations, which may become the focal point for eventual failure of the device.
23
Distributed by:
Manufactured by:
Orthofix
3451 Plano Parkway
Lewisville, Texas 75056-9453 USA
214-937-2000
0086
1.888.298.5700
orthofix.com
JA-1607 © Orthofix Holdings, Inc. 10/2016
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Proper
surgical procedure is the responsibility of the medical professional. Operative techniques are furnished
as an informative guideline. Each surgeon must evaluate the appropriateness of a technique based
on his or her personal medical credentials and experience. Please refer to the “Instructions for Use”
supplied with the product for full information on indications for use, contraindications, warnings,
precautions, adverse reactions information and sterilization.