The Zimmer Spine Sequoia Pedicle Screw System is designed to
aid in the surgical correction of several types of spinal conditions.
This system is intended only to provide stabilization during the
development of a solid fusion with a bone graft. These implants are
intended to be removed after the development of a solid fusion mass.
The Sequoia Pedicle Screw System consisting of open style
polyaxial screws, titanium rods (varying lengths) and connectors is
intended to provide temporary stabilization following surgery to fuse
the spine. The polyaxial screw design allows the surgeon to use a
top-loading technique for dropping the spinal rod down to the fixation
components into a u-shaped opening.
This system offers a single package containing a wide array of
implant styles, allowing the surgeon maximum flexibility to address
SpeedLink II™ Transverse Connectors are provided to increase
rotational stiffness to the final construct.
When intended for pedicle screw fixation from T1-S1, the Sequoia
Pedicle Screw System is intended to provide immobilization and
stabilization of spinal segments in skeletally mature patients as an
adjunct to fusion in the treatment of the following acute and chronic
instabilities or deformities of the thoracic, lumbar, and sacral
spine: degenerative disc disease (defined as discogenic back pain with
degeneration of the disc confirmed by history and radiographic
studies), degenerative spondylolisthesis with objective evidence of
neurologic impairment, fracture, dislocation, deformities, or
curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, and
failed previous fusion. As a pedicle screw system placed between L3
and S1, the indications include Grade 3 or Grade 4 spondylolisthesis,
when utilizing autologous bone graft, when affixed to the posterior
lumbosacral spine, and intended to be removed after solid fusion is
established. When intended for non-pedicle, posterior screw fixation
of the non-cervical spine (T1- S1), the indications are idiopathic
scoliosis, neuromuscular scoliosis/kyphoscoliosis with associated
paralysis or spasticity, scoliosis with deficient posterior elements
such as that resulting from laminectomy or myelomeningocele, spinal
fractures (acute reduction or late deformity), degenerative disc
disease (back pain of discogenic origin with degeneration of the disc
confirmed by history and radiographic studies), tumor,
spondylolisthesis, spinal stenosis, and failed previous fusion. When
intended for anterolateral screw, rod, and/or cable fixation of the
T6-L5 spine, the indications are degenerative disc disease (back 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, and failed
Following are specific warnings, precautions, and adverse effects
that should be understood by the surgeon and explained to the patient.
These warnings do not include all adverse effects that can occur with
surgery in general, but are important considerations particular to
metallic internal fixation devices. General surgical risks should be
explained to the patient prior to surgery.
- IN THE U.S.A., THIS PRODUCT HAS LABELING LIMITATIONS.
- 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 secondary to degenerative spondylolisthesis with
objective evidence of neurologic impairment, fracture,
dislocation, scoliosis, kyphosis, spinal tumor and failed previous
fusion (pseudarthrosis). The safety and effectiveness of these
devices for any other conditions is unknown.
- BENEFIT OF
SPINAL FUSIONS UTILIZING ANY PEDICLE SCREW FIXATION SYSTEM HAS NOT
BEEN ADEQUATELY ESTABLISHED IN PATIENTS WITH STABLE SPINES.
Potential risks identified with the use of this device system,
which may require additional surgery, include:
- a. Device component fracture
- b. Loss of fixation
- c. Non-union
- d. Fracture of the vertebra
- e. Neurological
- f. Vascular or visceral injury
- CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. The
potential for satisfactory fixation is increased by the selection
of the proper size, shape and design of the implant. While proper
selection can help minimize risks, the size and shape of human
bones present limitations on the size, shape, and strength of
implants. Metallic 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.
- IMPLANTS CAN BREAK WHEN
SUBJECTED TO THE INCREASED LOADING ASSOCIATED WITH DELAYED UNION
OR NON-UNION. 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 metal 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.
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.
METALS CAN CAUSE CORROSION. There are many forms of corrosion
damage and several of these occur on metals surgically implanted
in humans. General or uniform corrosion is present on all
implanted metals and alloys. The rate of corrosive attack on metal
implant devices is usually very low due to the presence of passive
surface films. Dissimilar metals in contact, such as titanium and
stainless steel, accelerate the corrosion process of stainless
steel and more rapid attack occurs. The presence of corrosion
compounds released into the body system will also increase.
Internal fixation devices, such as rods, hooks, wires, etc. which
come into contact with other metal objects, must be made from like
or compatible metals.
- PATIENT SELECTION. In selecting
patients for internal fixation devices, the following factors can
be of extreme importance to the eventual success of the procedure:
- The patient’s weight.
An overweight or obese patient can produce loads on the device
that can lead to failure of the appliance and the
- The patient’s occupation or activity. If the
patient is involved in an occupationor activity that includes
substantial walking, running, lifting or muscle strain, the
resultant forces can cause failure of the device.
condition of senility, mental illness, alcoholism, or drug
abuse. These conditions, among others, may cause the patient
to ignore certain necessary limitations and precautions in the
use of the appliance, leading to implant failure or other
- Certain degenerative diseases. In some
cases, the progression of degenerative disease may be so
advanced at the time of implantation that it may substantially
decrease the expected useful life of the appliance. For such
cases, orthopaedic devices can only be considered a delaying
technique or temporary relief.
- Foreign body
sensitivity. Where material sensitivity is suspected,
appropriate tests should be made prior to material selection
- Smoking. Patients who smoke have
been observed to experience higher rates of pseudarthrosis
following surgical procedures where bone graft is used.