Indications
The Streamline OCT Occipito-Cervico-Thoracic System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion when using autograft and/or allograft for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 to 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 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 Streamline OCT System may be connected to the Quantum Spinal Fixation System, Streamline MIS Spinal Fixation System or Streamline TL Spinal System using connectors and/or transition rods.
Contraindications
Certain degenerative diseases or underlying physiological conditions such as diabetes or rheumatoid arthritis may alter the healing process, thereby increasing the risk of implant breakage.
Mental or physical impairment which compromises or prevents a patient’s ability to comply with necessary limitations or precautions may place that patient at a particular risk during postoperative rehabilitation.
Factors such as the patient’s weight, activity level, and adherence to weight bearing or load bearing instructions have an effect on the stresses to which the implant is subjected.
Warnings
The same medical/ surgical conditions or complications that apply to any surgical procedure may also occur during or following implantation of this device system. The surgeon is responsible for informing the patient of the potential risks associated with treatment, including complications and adverse reactions. The surgeon may need to perform additional surgery to address any complications or adverse reactions, which may or may not be device related.
The safety and effectiveness of pedicle screw spinal fixation 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, or sacral spine secondary to degenerative spondylolisthesis with objective evidence of neurological 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.
One of the potential risks identified with this system is death. Other potential risks which may require additional surgery, include:
- device component fracture
- loss of fixation
- non-union
- fracture of the vertebrae
- neurological injury, and
- vascular or visceral injury
The components of this device are manufactured from biocompatible implant grade materials. Mixing of certain implant components with different materials is not recommended for metallurgical, mechanical and functional reasons.
This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the thoracic (T4-T12) or lumbar spine.
No implant and screw system can withstand the sudden dynamic loads such as falls or other accidents.
Precautions
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. Preoperative planning and patient anatomy should be considered when selecting pedicle screw diameter and length. 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. Based on fatigue testing results, when using the system, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact the performance of the system. 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 bending, loosening, or breakage. Implants that have been notched or scratched must be discarded. Patients should be fully informed of the risks of implant bending, loosening, or breakage.
Only rods and crosslinks are intended to be bent or contoured. Bending of components other than rods and crosslinks may lead to premature material fatigue of the implant. If bending or contouring of components other than rods or crosslinks occurs, those components must be discarded.
Avoid creating a sharp bend or reversing a contour in the rod, as this may lead to premature material fatigue of the implant. Do not bend the rod in the reverse direction, as this may introduce micro fractures that compromise its strength. If reverse rod bending or excessive bending has occurred, the bent rod must be discarded. Please contact Customer Service at 888-778-8771 with any questions in regard to contouring the rod prior to surgery.
Mixing 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, accelerates 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.
Correct handling of the implant is extremely important. Contouring of the metal implants should only be done with proper equipment. The operating surgeon should avoid any notching, scratching or reverse bending of the devices when contouring. Implants that have been notched or scratched must be discarded. Alterations will produce defects in surface finish and internal stresses which may become the focal point for eventual breakage of the implant. Bending of screws will significantly decrease fatigue life and may cause fracture.
Removal of the implant after healing
Metallic implants can loosen, fracture, corrode, migrate, or possibly increase the risk of infection, cause pain, or stress shield bone even after healing, particularly in young, active patients. The surgeon should carefully weigh the risk versus benefits when deciding whether to remove the implant. Implant removal should be followed by adequate postoperative management to avoid re-fracture. If the patient is older and has a low activity level, the surgeon may choose not to remove the implant thus eliminating the risk involved with a second surgery.
Magnetic Resonance Imaging (MRI) Safety
System implants are manufactured using non-ferromagnetic materials. These implants have not been tested for safety and compatibility in the MR environment. These implants have not been tested for heating, migration, or image artifact in the MR environment. The safety of these implants in the MR environment is unknown. Scanning a patient who has these devices may result in patient injury.
See product specific surgical technique manual and package insert for complete instructions and labeling limitations.
