Revolution Spinal System® - Instructions for Use
Revolution Spinal System®
The Revolution Spinal System® implants are intended to be used as a construct that assists in normal healing and are not intended to replace normal body structures. The system is intended to stabilize the spinal operative site during posterior fusion procedures (T1-S1), attaching to the spine by means of screws joined with connectors. The components of the system are manufactured from Ti-6Al-4V ELI, conforming to ASTM F136.
Implants are provided STERILE. Each implant has been sterilized using gamma irradiation.
Instruments are provided either STERILE or NON-STERILE.
STERILE - Revolution MIS Access Kit (Catalogue No: 116220)
Revolution MIS Access Kit is packaged sterile. Each instrument kit has been sterilized using gamma irradiation. Instruments of the Revolution MIS Access Kit are sterile as long as the packaging has not been opened or damaged. Inspect the package before use. Do not use if the packaging has been received opened, torn, punctured, or damaged. Do not use if the seal has been inadvertently broken.
Instruments in the Revolution MIS Access Kit are for a single procedure use only. DO NOT REUSE. The instruments must be disposed of after use. Do not attempt to sterilize or clean the instruments. Cleaning or reuse may result in improper function of the instruments.
Modification, mishandling or reuse of the instruments will invalidate the calibration of the instrument and may result in improper function of the instrument.
The torque-limiting Instrument should not be used for any other function other than the manufacturer’s recommendations.
Do not exceed 30 actuations of the torque limit set point. Exceeding this number of actuations may void torque setting. Exceeding, disregarding or NOT following these parameters may cause the device to break and or not perform correctly.
NON-STERILE - Revolution Instruments
Instruments for the Revolution Spinal System® are also offered Non-Sterile. Non-sterile instruments must be cleaned and sterilized prior to each use. Non-Sterile instruments are packaged in sterilization trays. Non-sterile instruments should be stored in the sterilization trays until cleaned and sterilized. For Cleaning and Sterilization of the Revolution Non-Sterile, reusable Instruments see Care and Handling of Reusable Instruments IIS LBL 091614 Rev. B.
INDICATIONS FOR USE
The Revolution Spinal System® is intended for pedicle screw fixation of the non-cervical posterior spine in order 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: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) spondylolisthesis, (3) trauma (i.e., fracture or dislocation), (4) spinal stenosis, (5) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), (6) tumor, (7) pseudoarthrosis, (8) failed previous fusion.
Contraindications include but are not limited to:
- History of recent infection, systemic, spinal, or localized
- Morbid obesity
- Mental illness
- Alcoholism or drug abuse
- Fever or leukocytes
- Metal sensitivity/allergies to implant materials
- Severe osteopenia
- Presence of congenital abnormalities, vague spinal anatomy, tumors, or any other condition which may prevent secure implant screw fixation and/or decrease the useful life of the device.
- Any condition where the device will interfere with anatomical structures or physiological performance, including inadequate tissue coverage over the operational site.
- Patients unwilling or unable to follow post-operative care instructions
Any circumstances not described under INDICATIONS
- 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.
- The Revolution Spinal System® has not been evaluated for safety and compatibility in the magnetic resonance (MR) environment. The Revolution Spinal System® has not been tested for heating or migration in the MR environment.
- No components of the Revolution Spinal System® should be used with components from any other system or manufacturer. The Revolution Spinal System® delivery instrumentation should be used to implant and connect the devices. The use of any other drivers, taps, or other instrumentation may compromise the integrity of the construct.
- Refer to the Revolution Spinal System® Surgical Technique Manual for detailed implantation information. To obtain a Surgical Technique Manual, please contact Intelligent Implant Systems Customer Service Department at (704) 424-1009 or your Sales Representative.
- As with all orthopedic implants, none of the Revolution Spinal System® components should ever be reused under any circumstances.
- Based on fatigue testing results, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, and other patient conditions, etc. which may impact the performance of the system.
- The proper selection and compliance of the patient will greatly affect the results. Patients who smoke have been shown to have an increased incidence of non-union. These patients should be advised of this fact and warned of the consequences. Other poor candidates for spine fusion include patients who are obese, malnourished, have poor muscle or bone quality, or nerve paralysis patients.
- 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.
- Only those patients who meet the criteria of one or more of the indications and did not have conditions included in the CONTRAINDICATIONS should be selected for implantation.
- The implant components should be handled and stored carefully, protected from any damage, including corrosive environments.
- The surgeon must confirm that all necessary implants and instruments are on hand for the planned surgical construct. Components from other manufacturers should not be combined with components from the Revolution Spinal System®.
- Prior to use, inspect implant and instrument packaging to ensure there is no damage. If damage is observed, discontinue use and discard following appropriate institutional requirements.
- Extreme caution should be used around the spinal cord and nerve roots, especially when inserting the screws.
- Breakage, slippage, misuse, or mishandling of the instruments or implant components may cause injury to the patient or hospital personnel.
- The implants must be handled carefully to avoid notching or scratching of the surface.
- Before closing the soft tissue, all of the Lock Nuts should be locked securely according to the surgical technique.
- Explanted implants must never be reused.
- During construct assembly do not cross-thread Lock Nut-to-Bone Screw connection threads. Rotate connection threads counterclockwise 1-2 revolutions on the screw head before attempting to thread the Lock Nut onto the screw head.
- The surgeon must consider removing the implant after healing, as implants can loosen, fracture, or corrode even after fusion has occurred. The risks and benefits of a second surgery must be carefully evaluated.
- The patient should be instructed in the proper use of crutches, canes, and external braces, or any other weight bearing or assist devices that may be required. In addition, the patient should be instructed to limit those physical activities that would place excessive stresses on the implants or delay the healing process.
- The patient should also be instructed in the proper methods to ambulate, climb stairs, get in and out of bed, and perform activities of daily living, while minimizing the rotational and bending stresses.
POSSIBLE ADVERSE EFFECTS
- Pre-operatively, the patient should be made aware of the possible adverse effects of spinal implant surgery. Additional surgery may be necessary to correct some of these effects.
- Bending, loosening, or fracture of the implants.
- Metal sensitivity to a foreign body, including possible tumor formation.
- Skin or muscle sensitivity in patients with inadequate tissue coverage at the operative site, which may result in skin breakdown and / or wound complications.
- Non-union and delayed union.
- Nerve or vascular 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 impotency, and / or loss of consortium.
- Pain or discomfort.
- Bone loss due to resorption or stress shielding, or bone fracture above or below the level of surgery.
- Hemorrhage of blood vessels 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.
Implants should be handled with care at all times. Store away from areas of direct sunlight and sources of electro-magnetic radiation.
The Revolution Non-Sterile, reusable instruments must be completely dry before storing and must be handled with care to prevent damage. Store in designated tray in areas which provide protection from dust, insects, chemical vapors and extreme changes in temperature and humidity.
The Sterile Revolution MIS Access Kits should be handled with care at all times. Store away from areas of direct sunlight and sources of electro-magnetic radiation.
CAUTION: : Do not attempt surgical procedure with faulty, damaged, or suspect implants or instruments. Inspect all components preoperatively to assure utility. Alternative fixation methods should be available intraoperatively.
For further information on the Revolution Spinal System®, please contact:
Intelligent Implant Systems, LLC
3300 International Airport Drive
Charlotte, NC 28208
Phone: (704) 424-1009
Fax: (704) 424-1011
IIS LBL 091514 Rev. F