Set Synicem KYP System

Trade name

Set Synicem KYP System

03700448213501

B-03700448213501

Reference / catalog number

880677

GS1

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

This product has been developed to carry out the percutaneous treatment of vertebral bodies by means of the balloon kyphoplasty technique. Balloon Kyphoplasty is used for the percutaneous treatment of vertebral body fractures (especially in serious cases) when the aim is to restore the height of the vertebral body allowing to generate the cavity for the injection of bone cement. The accessories are offered in case you want to intervene on more than one vertebra in the same procedure.

Additional information URL

https://www.synimed.com/

Clinical sizes

• 20 MU50

European Medical Device Nomenclature — the EU product classification assigned to this device.

• A019011INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS

1 warning recorded — scroll inside the panel to see all entries.

• Warnings: Kyphoplasty must be carried out by surgeons with broad experience in this procedure, in a healthcare centre with all the necessary elements to guarantee the normal development of the procedure. The possibility of immediate accessing to treatment of any type of unwanted reaction in a patient must be available. Kyphoplasty must be carried out with real time fluoroscopy in order to control all the stages of the procedure. Balloon Kyphoplasty is contraindicated in patients with the following conditions: • Prophylaxis of potential vertebral collapse in patients with osteoporosis or metastasis with no evidence of vertebral fracture. • Coagulation disorders or inability to reverse the anticoagulant therapy. • Serious cardiopulmonary disease. • Serious vertebral fractures of traumatic origin. • Patients who show clear improvement with medical therapy. • Severe spinal stenosis with retropulsion of vertebral body fragments. • Anatomical damage of the vertebra that prevents safe access of instruments to the vertebral body. • Severe vertebral body collapse. • Fever. • Active infection or infection not treated completely. • Allergy history to any of the materials used in the procedure.

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