Orthofix GALAXY UNYCO SYSTEM, Инструкция

Страница: 5 / 124

5
18. The fixator should be applied at a sufficient distance from the skin to allow for post-operative swelling and for cleaning, remembering that the stability of the system depends
upon the bone-fixator distance. It is recommended to apply the Large Multiscrew Clamp for UNYCO Screws 4 cm from the bone.
19. Additional equipment may be required for fixation application and removal.
20. Once two or more UNYCO screws have been inserted in the Large Multiscrew Clamp for UNYCO Screws, the latter should not be moved along the screw shafts. Sliding the
clamp might cause loss of bone purchase.
21. In case of knee and/or ankle spanning, stabilization in the femur and foot must be performed with bicortical screws in conjunction with Galaxy Fixation System.
22. Screw and frame stability should be monitored at regular intervals. Weight-bearing or excessive loading may lead to loosening or disassembly.
23. If the system is perceived as impediment for application of the definitive treatment, remove the system parts where needed.
24. Meticulous screw site hygiene is required.
25. Patients should be instructed to report any adverse or unanticipated effects to the treating surgeon.
26. Removal of the device: the surgeon should make the final decision when to remove the device and replace it with definitive fixation.
27. Do not use components of the Orthofix Galaxy UNYCO Diaphyseal Tibia Kit in conjunction with products of other manufacturers, unless otherwise specified, as the combination
is not covered by the necessary validation.
POSSIBLE ADVERSE EFFECTS
1. Nerve or vessel damage resulting from insertion of screws.
2. Superficial or deep bone screw tract infection, osteomyelitis, or septic arthritis, including chronic drainage of bone screw sites after device removal.
3. Oedema or swelling; possible compartment syndrome.
4. Loosening or breakage of implants.
5. Bony damage due to inappropriate implants selection or application.
6. Persistence or recurrence of the initial condition requiring treatment.
7. Foreign body reaction to implants or frame components.
8. Tissue necrosis secondary to implants insertion.
9. Pressure on the skin caused by external components when clearance is inadequate.
10. Limb length discrepancy.
11. Excessive operative bleeding.
12. Intrinsic risks associated with anesthesia.
13. Intractable pain.
14. Vascular disorders including thrombophlebitis, pulmonary embolus, wound hematomas, avascular necrosis.
Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar
spine.
Important
A successful result is not achieved in every surgical case. Additional complications may develop at any time due to improper use, medical reasons or device failure which require
further surgical intervention to remove or replace the external fixation device. Preoperative and operative procedures including knowledge of surgical techniques and proper
selection and placement of the external fixation devices are important considerations in the successful utilization of Orthofix external fixation devices by the surgeon. Proper
patient selection and the patient’s ability to comply with physician instructions and follow prescribed treatment regimen will greatly affect the results. It is important to screen
patients and select optimal therapy given physical and/or mental activity requirements and/or limitations. If a surgical candidate exhibits any contraindications or is predisposed to
any contraindications, DO NOT USE Orthofix Galaxy UNYCO Diaphyseal Tibia Kit.
Materials
The Orthofix Galaxy UNYCO Diaphyseal Tibia Kit is comprised of stainless steel, aluminum alloy, titanium alloy and plastic components. Those components which contact the
patient are the percutaneous pins (UNYCO Screws and UNYCO Cancellous screws). These are manufactured from surgical grade stainless steel.