DESCRIPTION
The Cypher™ MIS Screw System is a non-cervical spinal
fixation device. The system includes screws, various types and sizes
of rods, and set screws. Various instruments are also available for
use by the surgeon to facilitate implantation of the device.
INDICATIONS
The Cypher MIS Screw System is a non-cervical spinal fixation
device intended for immobilization and stabilization as an adjunct to
fusion as a pedicle screw fixation system or sacral/iliac screw
fixation system for use with autograft and/or allograft. The Cypher
Instruments are intended to be used with the Cypher/Polaris™ 5.5
implants. Cannulated screws and percutaneous rods may be used with the
Cypher instruments to provide the surgeon with a percutaneous approach
for posterior spinal surgery for the following conditions:
degenerative disc disease (defined as discogenic back pain with
degeneration of the disc confirmed by history and radiographic
studies), spondylolisthesis, trauma, (i.e., fracture or dislocation),
deformity or curvature (i.e., scoliosis, kyphosis, Scheuermann’s
disease, and/or lordosis), tumor, stenosis, pseudoarthrosis, and
failed previous fusion.
The Cypher MIS Screw System may be used with the instruments
in the AccuVision® Minimally Invasive Spinal Exposure
System to provide the surgeon with a minimally invasive approach for
posterior spinal surgery.
CONTRAINDICATIONS
- Spinal infection
- Morbid obesity
- A patient
who in the surgeon’s opinion is not psychosocially, mentally or
physically able to fully comply with the post-operative treatment
regime (e.g., mental illness, alcoholism or drug abuse.)
- Pregnancy
- Metal sensitivity/foreign body sensitivity
- Patients with inadequate tissue coverage over the operative
site
- Open wounds local to the operative area
- Direct
current stimulation, when used in a construct that includes
Translation Screws
WARNINGS
- 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
neurologic impairment, fracture, dislocation, scoliosis, kyphosis,
spinal tumor, and failed previous fusion (pseudarthrosis). The
safety and effectiveness of these devices for any other conditions
are unknown. Potential risks identified with the use of this device,
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.
- Implant Strength and Loading. The Cypher MIS Screw System
is intended to assist healing and is not intended to replace
normal bony structures. Loads produced by weight bearing and
activity levels will dictate the longevity of the implant. These
devices are not designed to withstand the unsupported stress of full
weight bearing or load bearing, and cannot withstand activity levels
and/or loads equal to those placed on normal healthy bone. If
healing is delayed or does not occur, the implant could eventually
break due to metal fatigue.
Therefore, it is important that
immobilization of the operative site be maintained until firm bony
union (confirmed by clinical and radiographic examination) is
established. The surgeon must be thoroughly knowledgeable in the
medical, surgical, mechanical and metallurgical aspects of the
Cypher MIS Screw System. Postoperative care is extremely
important. The patient should be warned that noncompliance with
postoperative instructions could lead to breakage of the implant
and/or possible migration requiring revision surgery to remove the
implant. - Selection of Implants. Selection of the proper size,
shape and design of the implant increases the potential for success.
While proper selection can help minimize risks, the size and shape
of human bones present limitations on the size and strength of
implants.
- Metabolic bone disease such as severe osteoporosis
may adversely affect adequate fixation of the implants due to the
poor quality of the bone.
- The surgeon must ensure that all
necessary implants and instruments are on hand prior to surgery.
They must be handled and stored carefully, protected from damage,
including from corrosive environments. They should be carefully
unpacked and inspected for damage prior to use. All nonsterile
components and instruments must be cleaned and sterilized before
use.
Zimmer Biomet Spine implants should not be used with
implants or instruments from another manufacturer for reasons of
metallurgy, mechanics and design. - Corrosion. Contact of
dissimilar metals accelerates the corrosion process, which could
increase the possibility of fatigue fracture of the implants.
Therefore, only use like or compatible metals for implants that are
in contact with each other. Never use stainless steel and titanium
implant components in the same construct. Cobalt Chrome Alloy rods
should not be used with Stainless Steel Components. Cobalt Chrome
Alloy rods are to be used ONLY with titanium implant components in
the same construct.
- The Cypher MIS Screw System has
not been evaluated for safety and compatibility in the MR
environment and has not been tested for heating or migration in the
MR environment.
- 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.
PRECAUTIONS
- Do not reuse implants/devices. While an implant/device may
appear undamaged, previous stress may have created imperfections
that would reduce the service life of the implant/ device. Do not
treat patients with implants/devices that have been even momentarily
placed in or used on a different patient.
- Handling of
Implants. If contouring of the rod is required, avoid sharp bends
and reverse bends. Avoid notching or scratching of the device, which
could increase internal stresses and lead to early breakage.
- Implant Removal After Healing. After healing is complete, the
implant is intended to be removed since it is no longer necessary.
Implants that are not removed may result in complications such as
implant loosening, fracture, corrosion, migration, pain or stress
shielding of bone, particularly in young, active patients. Implant
removal should be followed by adequate postoperative
management.
- Adequate Patient Instructions. A patient must be
instructed on the limitations of the metallic implant, and should be
cautioned regarding physical activity and weight bearing or load
bearing prior to complete healing.
- Surgical Techniques. The
implantation of pedicle screw spinal systems should be performed
only by experienced spinal surgeons with specific training in the
use of pedicle screw spinal systems because this is a technically
demanding procedure presenting a risk of serious injury to the
patient. Please refer to the specific surgical technique for this
device for more information. For a copy of the surgical technique,
please contact your sales representative, or customer service at the
address provided on the cover.
POSSIBLE ADVERSE EFFECTS
- Nonunion (pseudarthrosis) fibrous union (pseudoarthrosis),
delayed union or mal-union
- Loss of fixation malfunction,
disassembly, pull-out, or bending, fracture, loosening or migration
of the implant or instruments
- Metal sensitivity or foreign
body reaction to implant materials including corrosion by-products
due to use of dissimilar implant materials, possible tumor
formation, skin or muscle sensitivity in patients with inadequate
tissue coverage over the operative site, which may result in skin
breakdown and/or wound complications
- Decrease in bone
density due to stress shielding
- Pain, discomfort, or
abnormal sensations including back/leg pain due to presence of the
implant or surgical procedure
- Nerve, soft tissue, or blood
vessel damage due to surgical trauma including loss of neurological
function, dural tears, radiculopathy, paralysis and cerebral spinal
fluid leakage
- Gastrointestinal, urological and/or
reproductive system compromise, including sterility, impotency
and/or loss of consortium
- Fracture of bony structures at,
above or below the level of surgery (fracture of the vertebra)
- Nerve root or spinal cord impingement
- Bursitis
- Necrosis of bone
- Hemorrhage of blood vessels, blood
clots, and/or hematomas
- Malalignment of anatomical
structures, including loss of proper spinal curvature, correction,
reduction and/or height
- Bone graft donor site pain
- Inability to resume activities of normal daily living
- Neurological, vascular or visceral injury
- Reoperation
- Infection/sepsis
- General surgical
complications including cardiac or respiratory issues, exposure to
radiation, thrombosis, skin irritation, wound problems, issues
related to anesthesia and/or allergic reaction to grafting
material
- Implant malposition
- Graft
settling/displacement
- Death