Orthofix TrueLok, Instruction Leaflet

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19. Excessive surgical bleeding.
20. Intrinsic risks associated with anesthesia.
21. Unmanageable pain.
22. Secondary bone sequestration due to rapid perforation of the cortex with accumulation of heat and bone
necrosis.
23. Vascular disorders, including thrombophlebitis, pulmonary embolism, wound hematoma, avascular necrosis.
Warning: This device is not approved for fixing or attachment by means of screws to posterior elements
(pedicles) of the cervical, thoracic or lumbar spinal column.
Important
Not all surgical cases are resolved with a positive result. Additional complications may arise at any time
due to improper use, for medical reasons or as a result of failure of the device, requiring surgery in order to
remove or replace the external fixing device.
Presurgical and surgical procedures, including knowledge of the surgical techniques and the correct selection
and positioning of the external fixation devices, are important aspects for the successful application of
Orthofix external fixation devices by the surgeon.
Proper selection of the patient and their ability to comply with the physician’s instructions and follow the
prescribed treatment regimen will have a significant influence on the results. It is important to conduct
patient screening and select the optimal therapy, while bearing in mind the requirements and/or limitations
in terms of physical and/or mental activity. Should a candidate for surgery have any contraindications or be
predisposed to any contraindications, DO NOT USE any Orthofix external fixation device.
MATERIALS
The Orthofix TrueLok External Fixation System is comprised of components made from stainless steel,
aluminium alloy and plastic. The components coming into contact with the patient’s body are the
percutaneous screws (bone screws), the K-wires, the drill bits, the guides used during insertion of the screws,
the trocars and bone depth measurement devices; said components are made from surgical device grade
stainless steel. Certain of the bone screws used in the Orthofix External Fixation are supplied with a thin
coating of hydroxyapatite (HA), applied as a spray, over the threaded portion of the shaft.
STERILE and NON STERILE products
Orthofix supplies certain external fixation devices as STERILE and others as NON STERILE. It is recommended
the product label be checked in order to determine the sterility of each device.
Sterile
The devices or kits supplied as STERILE carry a label indicating said status.
The contents of the package are STERILE unless the package is opened or damaged. Do not use the
device if the package has been opened or damaged.
Non Sterile
Unless indicated otherwise, the components of Orthofix external fixation devices are provided as NON
STERILE. Orthofix recommends that all non sterile components be properly cleaned and sterilized, following
the specific cleaning and sterilization procedures recommended. The integrity and performance of the
product is only guaranteed in the case the package is undamaged.
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