Balloon Kyphoplasty for Spinal Fractures | 合法醫療器材資訊網

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Kyphon™ Balloon Kyphoplasty

Risks of Balloon Kyphoplasty and vertebroplasty procedures

As with all surgical procedures, there are risks associated with the procedure, including serious complications, and though rare, some of which can be fatal. For complete information regarding indications for use, contraindications, warnings, precautions, adverse events, and methods of use, please reference the devices’ Instructions for Use included with the product.

The complication rate with Kyphon™ Balloon Kyphoplasty has been demonstrated to be low (< 1% procedure- and cement-related1).

Adverse events potentially associated with use of the Inflatable Bone Tamps (IBT):

Embolism of fat, thrombus or other materials resulting in symptomatic pulmonary embolism or other clinical sequelae ...