Medical Device: Bone Cement

Description of the Medical Device

The percutaneous vertebroplasty procedure uses minimally invasive techniques to inject bone cement into compressed vertebral fractures. The cement quickly hardens, stabilizing the spine and reducing pain, making it suitable for patients with osteoporosis.

When to Use

The vertebra fractures due to osteoporosis, trauma, or even cancer.

Possible Side Effects

• Bone cement leakage that causes nerve compression, leading to less than 1% (0.4%) of the patients suffer from paraplegia and about 1%-10% of the patients with nerve damages, among which about 10% are patients with metastatic tumor and 1% are patients with compression fracture from osteoporosis.
• Bone cement might flow into venous blood vessels during perfusion due to patient’s idiosyncrasy and result in pulmonary embolism, which might cause death. The incidence rate is less than 1%.
• After the vertebra reconstruction surgery, more fractures might occur due to the increased strength of the section that changes the endurance of the other sections. The incidence rate is between 12%-20% according to the data obtained from a two-year research conducted in foreign countries.
• Allergic to bone cement, which might result in shock and death. A case was reported in a foreign country. The allergic reaction was dramatic with very high death rate.
• Macrovascular injury, <1% of incidence rate.
• Meninges rupture that results in cerebrospinal fluid leakage, <1% of incidence rate.

Post Surgery Care

• Wear back brace for 1-3 months as instructed by the doctors.
• About 10% of the patients have chronic dull pain around waist after the surgery. The symptom may be treated with medication.
• Keep the wound dry.
• Please refer to post surgery care instruction paper for home care details.
• Periodical follow up visits.