In some cases, the progression of degenerative disease may be so advanced at the time of implantation that it may substantially decrease the expected useful life of the appliance. For such cases, orthopaedic devices can only be considered a delaying technique or temporary relief. Foreign body sensitivity. Where material sensitivity is suspected, appropriate tests should be made prior to material selection or implantation.
Elevators and band passers should not be used for sublaminar passage. They should only be used for passage around the transverse process. Medical Education Menu. Product Features. The Universal Clamp spinal implant system consists of three sterile parts furnished together: One clamp One woven polyester band One locking screw A great benefit of the system is its simplicity. The indications for use include the following applications: Spinal trauma surgery, used in sublaminar or facet wiring techniques.
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis and spondylolisthesis.
Spinal degenerative surgery, as an adjunct to spinal fusions. Disease conditions that have been shown to be safely and predictably managed without the use of fixation devices are relative contraindications to the use of these devices.
Active systemic infection, or infection localized to the site of the proposed implantation, are contraindications to implantation. Severe osteoporosis is a contraindication because it may prevent adequate fixation. Suspected or documented metal allergy or intolerance. Inadequate tissue coverage over the operative site. In any situation where implant utilization would interfere with anatomical structures or expected physiological performance, such as impinging on vital structures.
Severe fractures such that segments may not be maintained in satisfactory proximate reduction. Physical contact of the Universal Clamp System with dissimilar metals. The titanium clamp should only be used with titanium implants and the stainless steel clamp should only be used with stainless steel implants. Any entity or condition that compromises the possibility of fusion, i.
Other relative contraindications include obesity, pregnancy, certain degenerative disease, and foreign body sensitivity. Specifically, some patients may, because of their occupation or lifestyle, or because of conditions such as mental illness, alcoholism or drug abuse, place undue stresses on the implant.
In the U. Potential risks identified with the use of this device system, which may require additional surgery, include: -Device component fracture. Implants can break when subjected to the prolonged 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 fatigue.
The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant. Patients should be fully informed of the risks of implant failure. 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, accelerate 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. In selecting patients for internal fixation, the following factors can be of extreme importance to the eventual success of the procedure: a. An explanted implant should never be re-implanted. Even though the device appears undamaged, it may have small defects and internal stress patterns, which may lead to early breakage.
Implants can loosen, fracture, corrode, migrate, possibly increase the risk of infection, cause pain, or stress shield bone even after healing, particularly in young, active patients. Conventional industrial robots. Service contact Pre-Sales Technical advice Product finder. Remote service On-site service Spare parts service Training.
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