Description

The PAED EXTEND FLEX W/LIMB ONLY is a specialized pediatric orthopedic implant system designed to address the unique challenges of diaphyseal fractures in long bones such as the femur, tibia, humerus, radius, and ulna in young patients. This system offers a flexible intramedullary nailing solution, providing elastic and stable internal fixation, particularly beneficial when the medullary canal is narrow or when implant flexibility is crucial.

Key Features

• Material Options: The system includes nails made from both stainless steel and titanium, offering varying degrees of flexibility. Nail diameters range from 1.5mm to 4.5mm, with lengths between 300mm and 450mm.
• Pre-Curved Design: The nails are pre-curved, enhancing stability at the fracture site. Typically, two nails of equal size are used per bone, occupying 70–80% of the canal diameter.
• Minimally Invasive Techniques: Nails are inserted using minimally invasive methods, ensuring they do not cross the growth plate. They are designed to protrude slightly for easy removal post-healing, minimizing soft tissue irritation.

Interlock Clamps and Screws

• Clamps and Screws: Available in both stainless steel and titanium, with clamps matching the nail material. Screws are self-tapping and require specific instrumentation for insertion.
• Instrumentation: The system includes a comprehensive set of tools such as inserters, awls, drill bits, and removal tools, tailored to the specific needs of the procedure.

Surgical Technique

• Procedure Guidance: Detailed instructions cover patient positioning, implant sizing, and nail insertion, with fluoroscopy recommended throughout.
• Nail Management: Nails can be bent at the trailing ends for easier removal, with final impaction leaving a small portion protruding from the bone cortex.

Material and MRI Safety

• Material Composition: Nails are made from Grade 5 Ti6Al4V ELI titanium alloy or 1.4441 stainless steel.
• MRI Compatibility: The device is MR-Conditional, safe for use in MRI environments under specified conditions.

Care and Maintenance

• Sterilization: All components must be cleaned and sterilized before use. Reusable parts should be inspected for damage and lubricated appropriately.

Contraindications and Precautions

• Intended Use: Not suitable for unstable fractures, certain adult fractures, or patients with active infection or metal sensitivity.
• Warnings: Avoid mixing implant materials and ensure proper use of system-specific instruments.

This system is intended for use by qualified medical professionals, with federal law restricting its sale to or on the order of a physician. Proper adherence to guidelines ensures optimal outcomes and minimizes potential adverse effects such as implant migration or infection.