The PathFinder NXT ® Minimally Invasive Pedicle Screw System is the next step forward in MIS. Backed by a legacy of clinical success with the original PathFinder ® System, the PathFinder NXT System offers enhanced procedural freedom and streamlined workflow for a broad range of MIS procedures.
By offering intuitive and versatile implants and instrumentation, the PathFinder NXT System provides spine surgeons a solution to address multiple pathologies with a less invasive approach.
The Zimmer Spine PathFinder NXT system consists of polyaxial cannulated screws and rods and is intended to provide temporary stabilization following surgery to fuse the spine. A range of spinal rod lengths included with PathFinder NXT allows the surgeon to place polyaxial pedicle screws through an open or mini-open procedure.
The PathFinder NXT System is designed to aid in the surgical correction of several types of spinal conditions. This system is intended only to provide stabilization during the development of a solid fusion with autograft or allograft. These implants are intended to be removed after the development of a solid fusion mass.
The PathFinder NXT System only allows the placement of 5.5 mm titanium rods.
Following are specific warnings, precautions, and adverse effects that should be understood by the surgeon and explained to the patient. These warnings do not include all adverse effects that can occur with surgery in general, but are important considerations particular to metallic internal fixation devices. General surgical risks should be explained to the patient prior to surgery.
1. IN THE U.S.A., THIS PRODUCT HAS LABELING LIMITATIONS.
2. 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 secondary to 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 is unknown.
3. BENEFIT OF SPINAL FUSIONS UTILIZING ANY PEDICLE SCREW FIXATION SYSTEM HAS NOT BEEN ADEQUATELY ESTABLISHED IN PATIENTS WITH STABLE SPINES. Potential risks identified with the use of this device system, which may require additional surgery, include:
a) Device component fracture
b) Loss of fixation
d) Fracture of the vertebra
e) Neurological injury
f) Vascular or visceral injury
4. CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. The potential for satisfactory fixation is increased by the selection of the proper size, shape and design of the implant. 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.
5. 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. 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 failure. Patients should be fully informed of the risks of implant failure.
6. 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. which come into contact with other metal objects, must be made from like or compatible metals.
7. PATIENT SELECTION. In selecting patients for internal fixation devices, the following 7 factors can be of extreme importance to the eventual success of the procedure:
a) The patient’s weight. An
overweight or obese patient can produce loads on the
device that can lead to failure of the appliance and the operation.
b) The patient’s occupation or
activity. If the patient is involved in an occupation or
activity that includes substantial walking, running, lifting or muscle strain, the
resultant forces can cause failure of the device.
c) A condition of senility, mental
illness, alcoholism, or drug abuse. These