ChoiceSpine Ambassador Instrucciones De Uso

Ambassador® Anterior Cervical Plate System
Instruction for Use
Implants
General Description:
The ChoiceSpine Ambassador Anterior Cervical Plate System is intended
for anterior screw fixation to the cervical spine. The system consists of a
variety of bone plates and screws. The components are made from
titanium alloy such as described by ASTM F136. Plates and screws are
provided non-sterile and must be steam sterilized by the user prior to use.
Indications for Use:
The ChoiceSpine Ambassador Anterior Cervical Plate System is intended
for anterior cervical fixation (C2-T1) for the following indications:
degenerative disc disease (DDD) (defined as neck pain of discogenic origin
with degeneration of the disc confirmed by history and radiographic
studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal
stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or
lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Contraindications:
Contraindications include, but are not limited to:
•
Active infectious process in the patient, particularly in or adjacent to
the spine or spinal structures Signs of local inflammation
•
Morbid obesity
•
Pregnancy
•
Grossly distorted anatomy due to congenital abnormalities
•
Any medical or surgical condition which would preclude the potential
benefit of spinal implant surgery
•
Rapid joint disease, bone absorption, osteopenia, osteomalcia, or
osteoporosis. Osteopenia or osteoporosis
contraindication since this condition may limit the degree of
obtainable correction and/or the amount of mechanical fixation
•
Suspected or documented metal allergy or intolerance
•
Any patient in which implant utilization would interfere with
anatomical structures or expected physiological performance
•
Use of these implants is relatively contraindicated in patients whose
activity, mental capacity, mental illness, alcohol or drug abuse,
occupation or life-style may interfere with their ability to follow post-
operative instructions
•
Any time implant utilization would interfere with anatomical
structures or expected physiological performance
•
Any case not needing a bone graft and fusion or where fracture healing
is not required
Warnings and Precautions:
The ChoiceSpine Ambassador Anterior Cervical Plate System should only
be implanted by surgeons who are fully experienced in the use of such
implants and the required specialized spinal surgery techniques. Further,
the proper selection and compliance of the patient will greatly affect the
results. The surgeon should consider the patient conditions (e.g., smoker,
malnutrition, obesity, alcohol and drug abuse, poor muscle and bone
quality), which may impact system performance. The ChoiceSpine
Ambassador Cervical Plate System is only a temporary implant used for the
correction and stabilization of the cervical spine. The system is also used
to augment the development of a spinal fusion by providing temporary
stabilization. This system is not intended to be the sole means of spinal
support. Autogenous bone grafting must be part of the spinal fusion
procedure in which the ChoiceSpine Ambassador Anterior Cervical Plate
System is used. Use of this product without an autogenous bone graft may
not be successful. The spinal implant cannot stand body loads without the
support of bone. In this event, bending, loosening, disassembly and/or
breakage of the device will eventually occur.
Based on fatigue testing results, when using the Ambassador Cervical
Plate, 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 this system.
The ChoiceSpine Ambassador Anterior Cervical Plate System has not been
evaluated for safety and compatibility in the MR environment. The
Ambassador Cervical Plate System has not been tested for heating,
migration, or image artifact in the MR environment. The safety of the
Ambassador Cervical Plate System in the MR environment is unknown.
Scanning a patient who has this device may result in patient injury.
Preoperative:
A successful result is not achieved in every surgical case, especially in spinal
surgery where many extenuating circumstances may compromise results.
Preoperative planning and operating procedures, including knowledge of
surgical techniques, proper reduction, and proper selection and placement
of the implant are critical considerations in achieving a successful result.
Only patients that meet the criteria described in the indications should be
selected. Patient conditions and/or predispositions such as those
mentioned in the contraindications should be avoided.
Care should be used in the handling and storage of the implant
components. The implants should not be scratched or otherwise damaged.
Implants and instruments should be protected during storage, especially
from corrosive environments. The type of construct to be assembled for
the case should be determined prior to beginning the surgery. An
adequate inventory of sizes should be available at the time of surgery,
including sizes larger and smaller than those expected to be used.
Since mechanical parts are involved, the surgeon should be familiar with
the various components before using the equipment and should
personally assemble the devices to verify that all parts and necessary
instruments are present before the surgery begins. All components and
instruments must be cleaned and sterilized prior to use. Additional sterile
components should be available in case of unexpected need. Prior to
surgery, the patient must be informed of all potential risks and adverse
effects contained in the present instructions for use.
Intraoperative:
The vertebral levels to be fixated should be well visualized with a linear
anterior surface so that the plate will mount flush with the anterior
cervical spine. The ChoiceSpine Ambassador Anterior Cervical Plate comes
with a standard lordotic curve. When the configuration of bone cannot be
fitted with an available temporary fixation device, and contouring is
absolutely necessary, it is recommended that such contouring be gradual
and great care be used to avoid notching or scratching the surface of the
device(s). The components should not be repeatedly or excessively bent
more than absolutely necessary. The components should not be reverse
bent at the same location. Bending near the screw holes should be
avoided.
The surgeon should follow established practices and specific instructions
for implant of the system. Whenever possible or necessary, an imaging
system should be utilized to verify proper component placement.
Extreme caution should be used around the spinal cord and nerve roots.
Damage to the nerves will cause loss of neurological functions.
2797
Always orient the Ambassador Cervical Plate as close as possible to the
ChoiceSpine, LLC
400 Erin Drive
spinal midline.
Knoxville, TN 37919
USA
The appropriately sized plate should be selected with the plate holes
directly anterior to the vertebrae to be fused.
Before closing the soft tissues, ensure that the locking cam has been
rotated to the lock position. Autogenous bone grafts must be placed in the
area to be fused. Bone cement should not be used since this material will
make removal of the components difficult or impossible. The heat from
the curing process may cause neurological damage and bone necrosis.
Some degree of corrosion occurs on all implanted metal and alloys. Mixing
of dissimilar metals can accelerate the corrosion process.
Stainless steel and titanium implants must NOT be used together in
building a construct.
Different manufacturers use different materials, varying tolerances and
design configurations. Components of the ChoiceSpine Ambassador
Cervical Plate System must not be used with components from any other
system or manufacturer.
This device is not approved for screw attachment to the posterior
elements (pedicles) of the cervical, thoracic, or lumbar spine.
Postoperative:
The physician's post-operative directions and warnings to the patient and
the corresponding patient compliance are extremely important.
Detailed instructions on the use and limitations of the device should be
given to the patient. The patient should be instructed to limit and restrict
physical activities, especially lifting and twisting motions and any type of
is a relative
sport participation. Patients should be advised of their inability to bend at
the point of spinal fusion and taught to compensate for this permanent
restriction in body motion. The patient should be advised not to smoke or
consume alcohol during the bone graft healing process.
If a non-union develops or the components loosen, bend, and/or break,
the device(s) should be revised and/or removed immediately before
serious injury occurs. Failure to immobilize a delayed or nonunion of bone
will result in excessive and repeated stresses on the implant. By the
mechanism of fatigue these stresses can cause eventual bending,
loosening or breakage of the device(s).
After the spine is fused, these devices serve no functional purpose and
should be removed. If the device is not removed following completion of
its intended use, one or more of the following complications may occur:
(1) Corrosion, with localized tissue reaction or pain, (2) Migration of
implant position possibly resulting in injury, (3) Risk of additional injury
from postoperative trauma, (4) Bending, loosening and/or breakage,
which could make removal impractical or difficult, (5) Pain, discomfort, or
abnormal sensations due to the presence of the device, (6) Possible
increased risk of infection, and (7) bone loss due to stress shielding. The
surgeon should carefully weigh the risk versus benefits when deciding
whether to remove the implant.
Implants must not be reused. Any implant, once used, should be discarded
even though it may appear undamaged.
Potential Complications and Adverse Effects:
Potential complications and adverse effects for this system are similar to
those of other spinal instrumentation systems, and include, but are not
limited to:
1. Early or late loosening of the components
2. Disassembly, bending or breakage of any or all of the components
3. Foreign body (allergic) reaction to the implants
4. Infection
5. Non-union(pseudarthrosis)
6. Loss of neurological function, including paralysis (complete or
incomplete), radiculopathy, dysesthesia, hyperesthesia, anesthesia,
paresthesia, development or continuation of pain, numbness,
neuroma, tingling sensation, dural tears, neuropathy, neurological
deficits (transient, permanent, or delayed), reflex deficits, bilateral
paraplegia, and/or arachnoiditis
7. Hemorrhage, hematoma, seroma, embolism, edema, stroke, excessive
bleeding, phlebitis, wound necrosis, or wound dehiscence
8. Misalignment of anatomical structures or loss of spinal mobility
9. Bone graft donor complications including pain, fracture or wound
healing problems
10. Atelectasis
11. Retropulsion of graft
12. Cessation of any potential growth of the operated portion of the spine
13. Injury to the neck, including the esophagus, trachea, carotid artery,
larynx, or laryngeal nerves
14. Early or late hoarseness, dysphagia, or dysphonia
15. Vascular damage resulting in excessive bleeding.
16. Loss or impairment of bowel, sexual, and/or bladder function and
other types of urological compromise.
17. Fracture, damage, degenerative changes or instability of any bone
above and/or below the level or surgery.
18. Gastrointestinal system compromise
19. Bone loss due to resorption or stress shielding
20. Death
How Supplied:
The ChoiceSpine Ambassador Anterior Cervical Plate devices are
provided clean but non-sterile and must be sterilized prior to use. Implants
are intended for single use only. Instruments can be reprocessed using the
recommended cleaning instructions.
Cleaning and Decontamination:
All instruments and implants are supplied to the health care facility clean
but non-sterile. Implants are single use only but need to be sterilized
before each use. Additionally, all instruments that have been previously
taken into a sterile surgical field must first be decontaminated and cleaned
using established hospital methods before sterilization and reintroduction
into a sterile surgical field. Implants that have been implanted and then
removed must be discarded. Cleaning and disinfecting of instruments can
be accomplished by using alkali aldehyde-free solvents at high
temperatures. Cleaning and decontamination can include the use of
neutral cleaners followed by a deionized water rinse.
Note: Certain cleaning solutions such as those containing formalin,
glutaraldehyde, bleach and/or alkaline cleaners may damage some
devices, particularly instruments; these solutions should not be used.
All products should be treated with care. Improper use and handling may
lead to damage and possible improper functioning of the device.
These devices are packaged in a convenience caddy/case. All devices must
be removed from the case, inspected and cleaned via one of the
appropriate methods below. Where applicable, instruments should be
disassembled prior to cleaning and reassembled prior to sterilization. All
devices must be placed back into the caddy and case prior to steam
sterilization.
Recommended Cleaning:
The terms "Steris 444", "Enzol®" and "Prolystica®" are tradenames of
ultrasonic equipment and detergents utilized on the recommended
cleaning instructions. Any ultrasonic washer or equivalent ultrasonic
detergent can be utilized when used in accordance to the manufacturer's
instructions and labeling.
Automated Cleaning:
1. Rinse instrument(s) under cool running tap water (< 35 °C) to remove
gross soil. Use a sterile syringe to flush water through and around
cracks, crevices, and hard to reach areas.
2. Use a soft bristle brush as needed to remove soil, paying close
attention to threads, crevices, and hard to areas.
3. Transfer instrument(s) into a STERIS 444 washer with the following
parameters. Incline the instrument(s) to assist in drainage. Motor
speed: High
Time
Phase Temperature
(min)
Pre-Wash 1 1:00 Cold Tap Water
1:00 Hot Tap Water
Enzyme Wash
Wash 1 2:00 60°C
Rinse 1 1:00 Hot Tap Water
Drying 7:00 115°C
4. Remove instrument(s) from washer & visually inspect for soil. Repeat
if necessary.
Mechanical Cleaning (Ultrasonic):
1. Rinse instrument(s) under cool running tap water (< 35 °C) to remove
gross soil. Use a sterile syringe to flush water through & around cracks,
crevices, & hard to reach areas.
2. Prepare Enzol® solution of one (1) ounce per one (1) gallon of warm
tap water (< 55 °C).
3. Fully immerse instrument(s) in the detergent for at least one (1)
minute.
4. Use a soft bristle brush as needed to remove soil, paying close
attention to threads, crevices, & hard to reach areas.
5. Use a sterile syringe to flush detergent through & around cracks,
crevices, & hard to reach areas.
6. Remove instrument(s) from detergent & rinse with cool tap water (<
35°C) for at least one (1) minute.
7. Prepare the ultrasonic cleaner with an Enzol® solution of one (1) ounce
per one (1) gallon of warm tap water (< 55°C).
8. Load instrument(s) into the cleaner & sonicate for ten (10) minutes.
9. Remove instrument(s) from cleaner & thoroughly rinse using reverse
osmosis/deionized (RO/DI) water for at least one (1) minute.
10. Dry instrument(s) using a clean, soft towel & filtered, pressurized air
(20 psi).
11. Visually inspect for soil. Repeat if necessary.
Manual Cleaning:
1. Rinse instrument(s) under cool running tap water (< 35 °C) to remove
gross soil. Use a sterile syringe to flush water through & around cracks,
crevices, & hard to reach areas.
2. Prepare Enzol® solution of one (1) ounce per one (1) gallon of warm
tap water (< 55 °C).
3. Fully immerse instrument(s) in the detergent for at least one (1)
minute.
4. Use a soft bristle brush as needed to remove soil, paying close
attention to threads, crevices, & hard to reach areas.
5. Use a sterile syringe to flush detergent through & around cracks,
crevices, & hard to reach areas.
6. Remove instrument(s) from detergent & thoroughly rinse with reverse
osmosis/deionized (RO/DI) water for at least one (1) minute. Use a
sterile syringe to aid in rinsing.
7. Dry instrument(s) using a clean, soft cloth & filtered, pressurized air
(20 psi).
8. Visually inspect for soil. Repeat if necessary.
Care and Handling:
•
All products should be treated with care. Improper use and handling
may lead to damage and possible improper functioning of the device.
•
Refer to ASTM standard F1744-96, "Standard Guide for Care and
Handling of Stainless Steel Surgical Instruments" for additional
information.
•
Before use, instruments should be visually inspected, and function
should be tested to ensure instruments are functioning properly. If
instruments are discolored, have loose screws/pins, are out of
alignment, cracked, show excessive wear, or have other irregularities.
DO NOT use.
•
Lubricate instruments to protect instruments during sterilization and
storage. This should be done with a water soluble, preserved lubricant
after each cleaning. The lubricant should contain a chemical
preservative to prevent bacterial growth and be made with distilled
water. Excess lubricant should be wiped off prior to storage and
sterilization.
Inspection:
The implants should be inspected after processing, prior to sterilization.
Any implant with damage, corrosion, discoloration, scratches, residue, or
debris should be discarded.
Sterilization:
ChoiceSpine instruments are provided non-sterile and must be sterilized
prior to use. All packaging materials must be removed prior to sterilization.
Instruments are recommended to be steam sterilized by the hospital using
the following process parameters:
Steam Sterilizer Type: Pre-vacuum
Temperature: 132°C
Duration: 4 minutes
Drying Time: 40 minutes
All devices are to be wrapped in two-layer of 1-ply polypropylene wrap
Detergent
N/A
Enzol® at 1 oz per 1 gal
water
Prolystica® 2x Conc.
Neutral at 1/8 oz per 1
gal water
N/A
N/A
IFUC-A002 Rev A 8/19