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Contraindications; General Warnings - Orthofix G-Beam Fusion Beaming System Gebrauchsanweisung

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PQ GBM A 02/18
EN
Instructions For Use are subject to change; the most current version of each Instruction For Use is always available online.
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Important information - please read prior to use
G-BEAM™ FUSION BEAMING SYSTEM
Orthofix Srl
Via delle Nazioni 9 - 37012 Bussolengo (VR) Italy
Tel. 0039 (0) 45 6719000 - Fax 0039 (0) 45 6719380
DESCRIPTION
The G-Beam™ Fusion Beaming System has been designed to address the specific demands of advanced deformity and trauma reconstructions of foot and ankle applications. The system was developed for the
treatment of neuropathic deformities, such as Charcot, requiring fusion of the medial and/or lateral columns, with or without corrective osteotomies as well as for joint fusions within the mid- and hindfoot.
The G-Beam™ Fusion Beaming System consists of two different diameter implant ranges, designed for optimal implant selection for wide ranging patient anatomies, and an instrumentation including the
dedicated G-Beam Sterilization Tray. The G-Beam™ Fusion Beaming System is designed with an instrumentation and technique that have been developed to simplify the surgery.
MATERIAL
The implants are made from stainless steel (AISI 316 LVM).
INDICATIONS FOR USE
The G-Beam™ Fusion Beaming System is intended to be inserted in the bones of the foot and ankle for alignment, stabilization and fixation of various fractures and osteotomies, fusions and reconstructions.
It is indicated for fracture and osteotomy fixation, reconstruction procedures, nonunions and fusions of bones of the foot and ankle including metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus.
Specific example: medial and lateral column fusions resulting from neuropathic osteoarthropathy (Charcot osteoarthropathy).

CONTRAINDICATIONS

1. Open epiphyses.
2. Active osteomyelitis or deep tissue infection at surgical site.
3. Infected ulcerations.
4. Patients with conditions that, in the surgeon's opinion, could jeopardize the treatment outcome.
5. Suspected or documented metal allergy or intolerance.
Proper patient selection and the patient's ability to comply with physician instructions and follow the 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 contraindication or is predisposed to any contraindication, DO NOT USE the G-Beam™.
NOTES FOR USE
The product is intended for professional use only. Surgeons who supervise the use of the product must have full awareness of orthopedic fixation procedures and should be familiar with the devices, instruments
and surgical procedure, including the application and removal. Detailed operative technique guidance is available on request; please contact Orthofix or your local distributor.
All Orthofix internal and external fixation products should be used together with their corresponding Orthofix implants, components and accessories. Their application should be performed with the specific
Orthofix instrumentation, following carefully the surgical technique recommended by the manufacturer in the appropriate Operative Technique Manual.

GENERAL WARNINGS

1. Preoperative procedures, knowledge of surgical technique and proper selection and placement of the implant are important aspects for the successful use of the device.
2. Do not use if packaging is compromised or if a component is believed to be faulty, damaged or suspect.
3. Implanted devices should never be re-used or re-sterilized. An explanted metal implant should never be re-implanted.
4. Any implant that has come into contact with bone, blood and/or bodily fluids and was not implanted shall be discarded.
5. Instruments, guide wires and screws are to be treated as sharps.
6. Instrumentation is made of materials that are not designed to be left inside the patient's body, either as a whole or in part due to breakage.
7. Use of an undersized G-Beam™ may lead to implant fracture and failure.
8. Use of an oversized G-Beam™ may lead to bone damage and/or breakage.
9. Advise the patient to report any unusual changes to the operative site to the surgeon. Closely monitor patients if a change in the fixation site has been detected.
10. The design of the instruments must not be modified in any way.
11. The G-Beam™ is not intended for screw attachment or fixation in the spine.
12. Always implant and remove the G-Beam™ by means of the dedicated Orthofix instrumentation, unless otherwise specified.
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