The Zimmer Biomet Spine Virage™ OCT Spinal Fixation System is
a posterior system intended for the Occipital-Cervical-Thoracic spine
(Occiput-T3). The system consists of a variety of rods, anchors,
transverse connectors, screws, and polyaxial screws to achieve an
implant construct as necessary for the individual case. The system
also includes the instruments necessary for inserting and securing the
implants. The implant system is intended to be removed after solid
fusion has occurred.
The Virage System implants are fabricated from medical grade
titanium alloy and medical grade cobalt chromium alloy. Implants made
from medical grade titanium, medical grade titanium alloy, and medical
grade cobalt chromium may be used together. Never use titanium,
titanium alloy, and/or cobalt chromium with stainless steel in the
same construct. All implants are single use only and should not be
reused under any circumstances.
Refer to the Virage OCT Spinal Fixation System Surgical
Technique manual for additional information on how to use this device.
Contact your Zimmer Biomet Spine Sales Representative or Zimmer Biomet
Customer Service for a copy of the current Surgical Technique.
The Virage OCT Spinal Fixation System is intended to provide
immobilization and stabilization of spinal segments as an adjunct to
fusion for the following acute and chronic instabilities of the
craniocervical junction, the cervical spine (C1-C7) and the thoracic
spine from T1-T3; traumatic spinal fractures and/or traumatic
dislocations; instability of deformity; failed previous fusions (e.g.,
pseudoarthorsis); tumors involving the cervical spine; and
degenerative disease, including intractable radiculopathy and/or
myelopathy, neck and/or arm pain of discogenic origin as confirmed by
radiographic studies, and degenerative disease of the facets with
instability. The Virage OCT Spinal Fixation System is also
intended to restore the integrity of the spinal column even in the
absence of fusion for a limited time period in patients with advance
stage tumors involving the cervical spine in whom life expectancy is
of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, The Virage
OCT Spinal Fixation System may be connected to the Instinct Java
and Sequoia Spinal Systems offered by Zimmer Biomet Spine, using rod
connectors and transition rods. Refer to the Instinct Java and Sequoia
Spinal System package insert for a list of the system specific
indications of use.
The titanium Lentur™ Cable System to be used with the Virage
OCT Spinal Fixation System allows for cable attachment to the
posterior cervical or thoracic spine.
The Virage System is not designed or sold for any use except
as indicated. DO NOT USE THE VIRAGE SYSTEM IMPLANTS IN THE
PRESENCE OF ANY CONTRAINDICATION.
Contraindications include, but are not limited to:
- Overt infection or distant foci of infections.
inflammation, with or without fever or leukocytosis.
- Morbid obesity.
- Rapid joint disease,
bone absorption, osteopenia, and/or osteoporosis.
or documented metal allergy or intolerance.
- Any time
implant utilization would interfere with anatomical structures or
expedited physiological performance, such as impinging on vital
- Severe comminuted fractures such that segments
may not be maintained in satisfactory proximate reduction.
- Use in displaced, non-reduced fractures with bone loss.
- The presence of marked bone absorption or severe metabolic bone
disease that could compromise the fixation achieved.
prognosis for good wound healing (e.g., decubitis ulcer, end-stage
diabetes, severe protein deficiency, and/or malnutrition).
- Any case not needing a bone graft or fusion.
- Any case
not described in the indications.
WARNINGS AND PRECAUTIONS
Following are specific warnings, precautions, and adverse effects
associated with use of the Virage System that should be
understood by the surgeon and explained to the patients. General
surgical risk should be explained to the patients prior to surgery.
- Implantation of the Virage System should be performed
only by experienced spinal surgeons
- All implants are
intended for single use only. Single use devices should not be
re-used. Possible risks associated with re-use of single-use devices
- Mechanical malfunction
- Transmission of
- Metal sensitivity has
been reported following exposure to orthopedic implants. The most
common metallic sensitivities (nickel, cobalt, and chromium) are
present in medical grade stainless steel and cobalt-chrome
- The Virage System is a temporary internal
fixation device. Internal fixation devices are designed to stabilize
the operative site during the normal healing process. After healing
occurs, these devices serve no functional purpose and should be
removed. Implant removal should be followed by adequate
postoperative management to avoid fracture or refracture.
- Universal precautions should be observed by all end users that
work with contaminated or potentially contaminated medical devices.
Caution should be exercised when handling devices with sharp points
or cutting edges to prevent injuries during and after surgical
procedures and reprocessing.
Warning: The safety and effectiveness of pedicle screw spinal
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 conditions
Precaution: The implantation of spinal fixation systems
should be performed only by experienced spinal surgeons with
specific training in the use of these spinal systems because this is
a technically demanding procedure presenting a risk of serious
injury to the patient. Preoperative planning and patient anatomy
should be considered when selecting implant diameter and
Additional preoperative, intraoperative, and postoperative warnings
- PRE-OP PLANNING – Use of cross sectional imaging (i.e., CT
and/or MRI) for posterior cervical screw placement is recommended
due to the unique risks in the cervical spine. The use of planar
radiographs alone may not provide the necessary imaging to mitigate
the risk of improper screw placement. In addition, use of
intraoperative imaging should be considered to guide and/or verify
device placement, as necessary.
- Usage of automated cleaning
processes without supplemental manual cleaning may not result in
adequate cleaning of instruments.
- Proper handling,
decontamination (including pre-rinsing, washing, rinsing and
sterilization), storage and utilization are important for the long
and useful life of all surgical instruments. Even with correct use,
care and maintenance, they should not be expected to last
indefinitely. This is especially true for cutting instruments (e.g.,
bone awls/drills) and driving instruments (e.g., drivers). These
items are often subjected to high loads and/or impact forces. Under
such conditions, breakage can occur, particularly when the item is
corroded, damaged, nicked or scratched.
- Prior to use,
instruments should be visually inspected for wear and tested to
assure they are functioning properly. If instruments are discolored,
show evidence of corrosion, have loose screws/pins, are out of
alignment, are cracked or have other irregularities, Do Not Use.
Instrumentation that appears damaged should be returned to the
- Never use titanium, titanium alloy, and/or
cobalt chromium with stainless steel in the same implant construct;
otherwise, galvanic corrosion may occur. See DESCRIPTION section for
Virage System materials and compatibility information.
- If contouring of the implant is necessary for optimal fit, the
contouring should be gradual and avoid any notching or scratching of
the implant surface. Do not repeatedly or excessively bend the
implant. Do not reverse bend the plate or rods.
Plate outside of bend zone groove may result in cracking of Plate.
Surgeon should always inspect Plate before implanting.
- Occiput and pedicle bone integrity should be verified
- Care should be taken during occiput and pedicle preparation to
avoid penetrating too deep.
- Care should be taken to ensure
occipital screw is not driven in too deep
- Care should be
taken during bone preparation to avoid damage to the pedicle and to
the surgical instruments.
- Care should be taken to minimize
soft tissue damage during surgery.
- Care should be taken to
avoid removing excess material from the Lamina.
- Care should
be taken to avoid cross-threading screws and closure tops.
- If any implant or instrument comes in contact with a non-sterile
surface it should not be used.
- Adequately instruct the patient. Postoperative care and the
patient’s ability and willingness to follow instructions are one of
the most important aspects of successful bone healing. The patient
must be made aware of the limitations of the implant and that
physical activity and full weight bearing have been implicated in
fracture. The patient should understand that an implant is not as
strong as normal, healthy bone and will fracture if excessive
demands are placed on it in the absence of complete bone healing. An
active, debilitated, or demented patient who cannot properly use
weight-supporting devices may be particularly at risk during
- The Virage System is a
temporary internal fixation device. Internal fixation devices are
designed to stabilize the operative site during the normal healing
process. After healing occurs, these devices serve no functional
purpose and should be removed. Implant removal should be followed by
adequate postoperative management to avoid fracture or
- Complications and adverse reactions have been reported with
the use of similar spinal instrumentation systems. These adverse
effects, including the possibility of death, should be discussed
with the patient prior to surgery.
- Possible neurologic
operative/postoperative adverse reactions that may require medical
or surgical intervention (e.g., implant removal with or without
- Paralysis, complete or
incomplete. Delayed onset has occurred even when evoked potential
was unaffected during surgery
- Dural tear leading to
cerebrospinal fluid fistula or pseudo meningocele
spinal cord injuries not otherwise described due to positioning of
the spinal attachment device
- Laminar erosion
- Epidural bleeding
- Abnormal sensations
Possible device postoperative complications/adverse reactions that
may require medical or surgical intervention (e.g., implant removal
with or without re-instrumentation) include:
- Loosening, bending, breaking, disassembly, and/or migration of
- Collapse of a fracture and/or fusion
- Device failure
- Corrosion at the screw/locking
cap interface contributing to breakage, and/or pseudoarthrosis
- Discomfort or pain, soft tissue erosion, or protrusion due to
prominent implanted hardware
- Attachment device pullout,
especially with short constructs and osteoporotic bone
- Implant or graft extrusion through the skin
deformities, pain, skin breakdown, or residual neural compression
due to kyphosis or lordosis occurring at the top of the segment
- Bone loss or fracture due to stress
- Foreign body reaction to the device including tumor
formation, autoimmune disease, metallosis, and/or scarring
- Non-union or pseudoarthrosis
- Cessation of growth at the
- Discitis, arachnoiditis, and/or other types of
Possible general or local postoperative complications/adverse
reactions that may require medical or surgical intervention (e.g.,
implant removal with or without re-instrumentation) include:
- Deep vein thrombosis, thrombophlebitis,
and/or pulmonary embolism that may be fatal; may be due to patient
position and/or length of the surgical procedure
- Wound infection, deep or superficial, which may require
implant removal and/or other medical interventions
dehiscence, delayed wound healing, or hematoma
possibly severe in nature
- Urinary tract infection
- Blood vessel damage and/or blood loss or hemorrhage
- Fracture(s) of the bone
- Gastrointestinal, urological,
and/or reproductive system compromise including sterility,
impotency, and/or loss of consortium
- Bone graft donor site
- Inability to resume activities of normal daily