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When intended as an adjunct to fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the Vertex Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Occipitocervical Components: Plate Rod/Plates/Rods/Occipital Screws/Hooks
The occipitocervical plate rods, plates, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine. Occipitocervical constructs require bilateral fixation to C2 and below.
Note: Segmental fixation is recommended for these constructs.
Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The use of multi-axial screws are limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.
Titanium Atlas® Cable System to be used with the Vertex Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.
In order to achieve additional levels of fixation, the Vertex Reconstruction System may be connected to the CD Horizon® Spinal System rods with the Vertex rod connectors. Refer to the CD Horizon Spinal System package insert for a list of the CD Horizon Spinal System indications of use.
Contraindications include, but are not limited to:
All of the possible adverse events associated with spinal fusion surgery without instrumentation are possible. With instrumentation, a listing of potential adverse events includes, but is not limited to:
A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where many extenuating circumstances may compromise the results. This device system is not intended to be the sole means of spinal support. Use of this product without a bone graft or in cases that develop into a nonunion will not be successful. No spinal implant can withstand body loads without the support of bone. In this event, bending, loosening, disassembly and/or breakage of the device(s) will eventually occur. Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and proper selection and placement of the implants are important considerations in the successful utilization of the system by the surgeon. Further, 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-unions. These patients should be advised of this fact and warned of this consequence. Obese, malnourished, and/or alcohol abuse patients are also poor candidates for spine fusion. Patients with poor muscle and bone quality and/or nerve paralysis are also poor candidates for spine fusion.
Warning: 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.
Precaution: 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. Physician Note: Although the physician is the learned intermediary between the company and the patient, the important medical information in this document should be conveyed to the patient.
Caution: Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only.
Other preoperative, intraoperative, and postoperative warnings and precautions are as follows:
The selection of the proper size, shape and design of the implant for each patient is crucial to the success of the procedure. Metallic surgical implants are subject to repeated stresses in use, and their strength is limited by the need to adapt the design to the size and shape of human bones. Unless great care is taken in patient selection, proper placement of the implant, and postoperative management to minimize stresses on the implant, such stresses may cause metal fatigue and consequent breakage, bending or loosening of the device before the healing process is complete, which may result in further injury or the need to remove the device prematurely.
The physician's postoperative directions and warnings to the patient, and the corresponding patient compliance, are extremely important.
Packages for each of the components should be intact upon receipt. If a loaner or consignment system is used, all sets should be carefully checked for completeness and all components including instruments should be carefully checked to ensure that there is no damage prior to use. Damaged packages or products should not be used, and should be returned to MEDTRONIC.
CLEANING AND DECONTAMINATION
Unless just removed from an unopened sterile MEDTRONIC package, all instruments and implants must be unpackaged, disassembled (if applicable) and cleaned before sterilization and introduction into a sterile surgical field or, if applicable, return of the product to MEDTRONIC. Remove all packaging materials prior to disassembly (if applicable) and cleaning. Cleaning instructions and associated disassembly instructions (if applicable) can be found at www.medtronic.com/manuals.
Note: certain cleaning solutions such as those containing formalin, glutaraldehyde, bleach and/or other alkaline cleaners may damage some devices, particularly instruments; these solutions should not be used unless instructed by the Instrument Care, Cleaning and Sterilization Quick Reference Guide part number 0381424. Also, many instruments require disassembly before cleaning.
All products should be treated with care. Improper use or handling may lead to damage and/or possible improper functioning of the device.
Unless marked sterile and clearly labeled as such in an unopened sterile package provided by the company, all implants and instruments used in surgery must be sterilized by the hospital prior to use. Remove all packaging materials prior to sterilization. Only sterile products should be placed in the operative field. Unless specified elsewhere, these products are recommended to be steam sterilized by the hospital using one of the sets of process parameters below:
|METHOD||CYCLE||TEMPERATURE||EXPOSURE TIME||DRY TIMES|
NOTE: Because of the many variables involved in sterilization, each medical facility should calibrate and verify the sterilization process (e.g. temperatures, times) used for their equipment.
*For outside the United States, some non-U.S. Health Care Authorities recommend sterilization according to these parameters so as to minimize the potential risk of transmission of Creutzfeldt-Jakob disease, especially of surgical instruments that could come into contact with the central nervous system.
Any Health Care Professional (e.g., customer or user of this system of products), who has any complaints or who has experienced any dissatisfaction in the product quality, identity, durability, reliability, safety, effectiveness and/or performance, should notify the distributor or MEDTRONIC. Further, if any of the implanted spinal system component(s) ever “malfunctions,” (i.e., does not meet any of its performance specifications or otherwise does not perform as intended), or is suspected of doing so, the distributor should be notified immediately. If any MEDTRONIC product ever “malfunctions” and may have caused or contributed to the death or serious injury of a patient, the distributor should be notified immediately by telephone, fax or written correspondence. When filing a complaint, please provide the component(s) name and number, lot number(s), your name and address, the nature of the complaint and notification of whether a written report from the distributor is requested.
Recommended directions for use of this system (surgical operative techniques) are available at no charge upon request. If further information is needed or required, please contact MEDTRONIC.