The Lineum OCT Spine System is an occipito-cervico-thoracic spinal
fixation system. The system includes bone screws, locking plugs,
various types and styles of rods, hooks, lateral connectors, set
screws, occipital plates, rod connectors/dominos and cross connectors.
For occipito-cervico-thoracic fusion, the occipital plate is fixed to
the occiput with bone screws. Rods may be cut to the appropriate
length. The rod is inserted and the construct is locked with plugs.
Cross connectors can be added to the construct for additional stability.
The Lineum OCT Spine 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 to C7) and the thoracic spine
(T1-T3): traumatic spinal fractures and/or traumatic dislocations;
instability or deformity; failed previous fusions (e.g
pseudarthrosis); tumors involving the cervical/thoracic 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 Lineum OCT Spine 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 advanced 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 Lineum OCT
Spine System can also be connected to the Biomet® Polaris
System via transitional rods or using the Altius Rod Connectors or
Polaris Dominoes. Please refer to the individual system’s package
insert for a list of indications for use for each system.
- Active systemic infection or infection local to operative
- Morbid obesity
- A patient who in the surgeon’s
opinion is not psychosocially, mentally or physically able to fully
comply with the postoperative treatment regimen (e.g., mental
illness, alcoholism or drug abuse)
sensitivity/foreign body sensitivity
- Patients with
inadequate tissue coverage over the operative site
wounds local to the operative area
- 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 Lineum OCT Spine 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 mechanical and metallurgical
aspects of the Lineum OCT Spine System.
- Postoperative care
is extremely important. Detailed instructions on the use and
limitations of the device should be given to the patient. The
patient should be warned that noncompliance with postoperative
instructions could lead to loosening or breakage of the implant
and/or possible migration requiring revision surgery to remove the
implant. The patient should be warned of these possibilities and
instructed to limit and restrict physical activities especially
lifting, twisting and any type of sport participation. Patients who
smoke have been shown to have an increased incidence of nonunion.
Therefore, these patients should be advised of this fact and warned
of the potential consequences.
- 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 size
limitations on the 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.
- Biomet spine implants should never
be used with implants or instruments from another manufacturer for
reasons of metallurgy, mechanics and design.
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 Lineum OCT Spine
System has not been evaluated for safety and compatibility in the MR
environment. The Lineum OCT Spine System has not been tested for
heating or migration in the MR environment.
- Do not reuse implants. While an implant may appear undamaged,
previous stress may have created imperfections that would reduce the
service life of the implant. Do not treat patients with implants
that have been even momentarily placed in or used on a different
- Handling of Implants. If contouring of the rod is
required, avoid sharp bends and reverse bends. Avoid notching or
scratching of implants, 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
- Surgical Techniques. The implantation of pedicle
screw spinal systems should be performed only by experienced spinal
surgeons with specific training in the use of this pedicle screw
spinal system 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 below. Preoperative planning and patient anatomy should be
considered when selecting implant diameter and length.
all times, extreme caution should be used around the spinal cord and
nerve roots. Damage to nerves may occur resulting in a loss of
- Bone grafts must be placed in the
area to be fused and the graft must contact viable bone.
- 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.
Possible Adverse Effects
Possible adverse effects include, but are not limited to:
- Bending, loosening or fracture of the implants or
- Loss of fixation;
- Sensitivity to a
metallic foreign body, including 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;
- Nonunion or delayed union;
- Nerve or vascular damage due to surgical
trauma, including loss of neurological function, dural tears,
radiculopathy, paralysis, and cerebral spinal fluid leakage;
- Pain or discomfort,
- Bone loss due to resorption or
stress shielding, or bone fracture at, above or below the level of
surgery (fracture of the vertebra);
- Hemorrhage of blood
vessels and/or hematomas;
- Malalignment of anatomical
structures, including loss of proper spinal curvature, correction,
reduction and/or height;
- Inability to
resume activities of normal daily living;