ChoiceSpine VEO Instrucciones De Uso

VEO® Lateral Access & Interbody
Fusion System
Instruction for Use
Fiber Optic Implants
Cable
General Description:
The VEO Lateral Access & Interbody Fusion System is a multi-component
system including instrumentation made of biocompatible materials such as
Stainless Steel, Aluminum, and Radel R and implants made of Tantalum
(ASTM F560) and PEEK (ASTM F2026) or Ti-6AI-4V ELI (ASTM F136).
Additional Resources:
A light source is required that is compatible with an ACMI connection to be
used with the Light Cable for the Stadium Mount Light
Indications for Use:
The VEO® Lateral Access & Interbody Fusion System is indicated for spinal
fusion procedures in skeletally mature patients with degenerative disc
disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as
discogenic back pain with degeneration of the disc confirmed by patient
history and radiographic studies. These DDD patients may also have up to
Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These
patients should have had six months of non-operative treatment. The VEO
Lateral Access & Interbody Fusion System is designed to be used with
autogenous and/or allogenic bone graft composed of cancellous and / or
corticocancellous bone graft, and supplemental spinal fixation that is
cleared for use in the lumbar spine.
Contraindications:
Contraindications include, but are not limited to, active systemic infection,
localized or spinal infection; morbid obesity; signs of local inflammation;
fever or leukocytosis; demonstrated allergy or foreign body sensitivity to
any implant materials; any medical or surgical condition which would
preclude or impede the potential benefit of spinal implant and/or spinal
fusion surgery, which could include, but not be exclusive to, elevated
erythrocyte sedimentation rate, unexplained inflammatory/disease
processes, elevation of white blood cell count (WBC), marked left shift in
the white blood cell count differential; distorted anatomy due to congenital
or remote posttraumatic/post infectious abnormalities; conditions that may
place excessive stresses on bone and implants, such as severe obesity or
degenerative diseases, osteopenia, and/or osteoporosis (osteoporosis is a
relative contraindication as this condition may limit the degree of
obtainable correction and/or height restoration, the amount of mechanical
fixation, and/or the quality of the bone graft); any case in which a bone graft
and fusion technique or where fracture fixation is not performed or
required; any operative case utilizing the mixing of dissimilar metals from
different components; patients having inadequate soft tissue coverage
over the operative site or where there is inadequate bone stock, bone
quality, or anatomical definition; any case not described in the indications;
patients whose activity, mental capacity, mental illness, alcoholism, drug
abuse, smoking, occupation, or lifestyle may interfere with their ability to
follow postoperative instructions and/or activity restriction guidelines and
who may place undue stresses on the implant during bony healing and may
be at a higher risk of implant failure.
Warnings:
The following warnings apply to components of the VEO Lateral Access &
Interbody Fusion System.
•
Refer to the Surgical Technique Guide to choose the correct size of
implant. Correct selection of the implant is important. The potential
for satisfactory anterior column support is increased by the selection
of the proper size device. While proper selection can help minimize
risks, the size and shape of human bones present limitations on the
size, shape and strength of implants. Internal fixation devices cannot
withstand activity levels equal to those placed on normal healthy
bone. No implant can be expected to withstand indefinitely the
unsupported stress of full weight bearing.
•
Patients must follow post-operative instructions as listed in the
Precautions section below. Not following post- op instructions can
result in delayed union or non-union. Implants can break when
subjected to the increased loading associated with delayed union or
nonunion. Internal fixation appliances are load sharing devices which
are used to obtain an alignment until normal healing occurs. If healing
is delayed, or does not occur, the implant may eventually break due
to material fatigue. The degree or success of union, loads produced by
weight bearing, and activity levels will, among other conditions,
dictate the longevity of the implant. The implant should be handled
with care during the surgery. Notches, scratches or bending of the
implant during the course of surgery may also contribute to early
failure. Patients should be fully informed of the risks of implant
failure.
•
The VEO Lateral Access and Interbody Fusion System device has not
been evaluated for safety and compatibility in the MR environment.
The VEO Lateral Access and Interbody Fusion System device has not
been tested for heating, migration, or image artifact in the MR
environment. The safety of the VEO Lateral Access and Interbody
Fusion System device in the MR environment is unknown. Scanning a
patient who has this device may result in patient injury.
Precautions
The following precautions apply to components of the VEO Lateral Access &
Interbody Fusion System. Physicians using this device should have
significant experience in spinal surgery, including spinal fusion procedures.
Physicians should not independently use this device prior to participation in
specific training on its use.
•
Surgical implants must never be reused. An explanted implant should
never be reimplanted. Even though a device appears undamaged, it
may have small defects and internal stress patterns which may lead to
early breakage.
•
Correct handling of the implant is extremely important, and it should
always be handled with care during surgery. Contouring of this implant
should not be done. The operating surgeon should avoid notching,
scratching or reverse bending of the implants. Alterations will produce
defects in surface finish and internal stresses which may become the
focal point for eventual breakage of the implant.
•
Postoperative instructions: Postoperative care and the patient's ability
and willingness to follow instructions are among the most important
aspects of successful bone healing. The patient must be made aware of
the limitations of the implants. The patient should be encouraged to
ambulate to tolerance as soon as possible after surgery, and instructed
to limit and restrict lifting and twisting motions and any type of sports
participation until the bone is healed. The patient should understand
that implants are not as strong as normal healthy bone and could
loosen, bend and/or break if excessive demands are placed on it,
especially in the absence of complete bone healing. Implants displaced
or damaged by improper activities may experience migration to the
devices and damage to nerves or blood vessels.
•
Postoperative external immobilization, i.e. bracing and /or casting is
recommended, at the surgeon's discretion, as is a comprehensive
postoperative core stabilization physical therapy program. Instructions
to the patient to reduce stress on the implant(s) are an equally
important component of the attempt to avoid the occurrence of clinical
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ChoiceSpine, LLC problems that may accompany fixation failure and delayed/non-union.
400 Erin Drive
•
Based upon surgeon preference, neuromonitoring may optionally be
Knoxville, TN 37919
used to map the psoas muscle (XL Pedicle Screw Probe). Refer to the
USA
VEO Lateral Access & Interbody Fusion System Surgical Technique
Manual and the XL Pedicle Screw Probe manufacturer's instructions for
usage details and instructions. Direct visualization is intended to allow
neural monitoring to be optional.
Possible Adverse Effects:
This list may not be inclusive of all possible complications caused by the
surgical procedure itself.
1. Bending or fracture of implant
2. Loosening and or collapse of the implant
3. Implant material sensitivity, or allergic reaction to a foreign body
4. Infection, early or late
5. Decrease in bone density due to stress shielding
6. Pain, discomfort, or abnormal sensations due to the presence of the
device
7. Nerve damage due to surgical trauma or presence of the device
8. Neurological difficulties including bowel and/or bladder dysfunction,
impotence, retrograde ejaculation, radicular pain, tethering of nerves
in scar tissue, muscle weakness, and paresthesia
9. Vascular damage could result in catastrophic or fatal bleeding.
Malposition implants adjacent to large arteries or veins could cause
erosion of these vessels and catastrophic bleeding in the later
postoperative period.
10. Dural tears experienced during surgery could result in need for further
surgery for dural repair, a chronic CSF leak or fistula, and possible
meningitis.
11. Bursitis
12. Paralysis
13. Death
14. Spinal cord impingement or damage
15. Fracture of bony structures
16. Reflex sympathetic dystrophy/Complex Regional Pain Syndrome,
Types I and II, including dyesthesias/hypesthesias
17. If a pseudarthrosis occurs, a mechanical grinding action could possibly
occur which might generate wear debris. Most types of wear debris
have shown the potential of initiating local osteolysis.
18. Degenerative changes or instability in segments adjacent to fused
vertebral levels
Additional surgery may be necessary to correct some of these potential
adverse effects.
How Supplied:
The VEO Lateral Access & Interbody Fusion System devices are
provided 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.
Fiber Optic Light Cable part # (25-2026) for domestic use only.
Cleaning and Decontamination:
All instruments must first be cleaned using methods recommended in this
document or established hospital methods before sterilization and
introduction into a sterile surgical field. Additionally, all instruments that
have been previously taken into a sterile surgical field must first be
decontaminated and cleaned using methods recommended in this
document or established hospital methods before sterilization and
reintroduction into a sterile surgical field. 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.
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 in 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 & around cracks,
crevices, & hard to reach areas.
2. Use a soft bristle brush as needed to remove soil, paying close attention
to threads, crevices, & hard to reach 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.
Phase
Pre-Wash 1
Enzyme Wash
Wash 1
Rinse 1
Drying
4. Remove instruments and inspect for soil, repeat cleaning 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.
Time
Temperature Detergent
(min)
1:00 Cold Tap Water N/A
Enzol® at 1 oz per 1 gal
1:00 Hot Tap Water
water
Prolystica® 2x Conc.
2:00 60°C Neutral at 1/8 oz per 1 gal
water
1:00 Hot Tap Water N/A
7:00 115°C N/A
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 (Alternative methods or cycles may be
used, but should be validated according to hospital practices and
procedures).
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
(Kimguard KC600 or equivalent) using various wrapping techniques per
ANSI/AAMI ST79.
This steam sterilization cycle is not considered by the FDA to be a standard
sterilization cycle. It is the end user's responsibility to use only sterilizers and
accessories (such as sterilization wraps or pouches, chemical or biological
indicators, and sterilization cassettes) that have been cleared by the FDA for
the sterilization cycle specifications (time and temperature). Alternative
sterilization methods or cycles may be used, but should be validated
according to hospital practices and procedures. The use of an FDA cleared
wrap is recommended to ensure devices remain sterile prior to
implantation.
Storage and Handling:
Implants should be stored in the implant sterilization case in clean, dry, well-
ventilated conditions away from floors, ceilings, and outside walls. Store
and transport sterile implants in such a way as to maintain sterility and
functional integrity. Do not use implants if the sterilization wrap is opened,
damaged or wet. Implants should remain covered until needed to avoid
contamination. Only those to be implanted should be handled.
Limitations and Restrictions:
Repeated sterilization according to these instructions has a minimal effect
on ChoiceSpine devices. Sterilization equipment varies in performance
characteristics and must be validated accordingly. The sterilizing facility is
responsible for the routine validation and monitoring of all equipment,
materials and personnel used in their facility to ensure the desired results
are achieved. These instructions have been validated as being capable of
sterilizing these ChoiceSpine implants and instruments. Any deviations from
these procedures must be evaluated for efficacy by the sterilizing facility.
Patient Education:
It is essential to provide preoperative instructions to the patient. S/he
should be made aware of the potential risks of the surgery and the implant
limitations. The patient should be instructed to limit postoperative activity,
as this will reduce the risk of bent, broken or loose implant components.
The patient must be made aware that implant components may bend,
break, or loosen even though restrictions in activity are followed.
Device Retrieval Efforts:
Should it become necessary to remove any or all of the VEO Lateral Access
& Interbody Fusion System components, please call ChoiceSpine at the
number below to receive instructions regarding data collection, including
histopathological, mechanical, and adverse event information.
Surgical Technique Manual:
The ChoiceSpine VEO Lateral Access and Interbody Fusion System Surgical
Technique Manual is available by contacting ChoiceSpine Customer Service.
IFUC-V001 Rev A 8/19