Orthofix GALAXY UNYCO SYSTEM Anleitungsfaltblatt Seite 4

2. Patients should be instructed to report any adverse or unanticipated effects to the treating surgeon.
3. Removal of the device: the surgeon should make the final decision when to remove the device and replace it with definitive fixation.
4. If faced with a segmental fracture, the most proximal and most distal bone segments are held using the Large Multiscrew Clamp for UNYCO Screws and the intermediate
segment can be held using a UNYCO Cancellous Screw in a Galaxy Large Clamp attached to the same connecting rod that links the two Large Multiscrew Clamps for UNYCO
Screws.
5. This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
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.
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 System.
Materials
The Orthofix Galaxy UNYCO System is comprised of stainless steel, aluminum alloy, titanium alloy and plastic components. Those components which contact the patient are the
UNYCO Screws . These are manufactured from implantable grade stainless steel.
Sterile
Devices or kits provided STERILE are labeled as such.
Contents of package are STERILE unless package is opened or damaged. Do not use if package is opened or damaged.
IMPORTANT: the Power Drill Torque Limiter and the Limited Torque Wrench 99-93567 must be discarded if package is opened or damaged.
Cleaning
WARNINGS: aluminum based devices are damaged by alkaline (pH>7) detergents and solutions. Anodised coating is damaged by detergents with free halogen ions or sodium
hydroxide. Detergents and disinfectants with fluoride, chloride, bromide, iodide or hydroxyl ions MUST NOT be used, except for disinfecting the UNYCO frame in preparation for
conversion surgery to definitive fixation.
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