Table 1 Material characteristics of the implant

Product Name

Bone Cement Bone Cement (REF66055104)

Manufacturers

Heraeus Medical GmbH (Heraeus Medical)

Specification Model

OSTEOPAL V

Approval Number

LOT 61,185,327

Structure and composition/main constituents

Osteopal V is a fast setting, radiation-impermeable bone cement for filling and stabilizing vertebrae. The product contains a powder and a liquid. The powder consists of methyl acrylate-methyl methacrylate polymer, zirconium dioxide, benzoyl peroxide, and copper chlorophyll (E141).The liquid consists of methyl methacrylate, N,N-dimethyl-p-toluidine, hydroquinone, and copper chlorophyllin (E141).

Scope of application/intended use

Osteopal V is indicated for filling and stabilization of the vertebral body: relief and elimination of pain in vertebral compression fractures, relief and elimination of pain in vertebral tumors (metastatic or bone marrow cancer), symptomatic vertebral hemangiomas.

Biocompatibility

Good

Adverse reactions

May cause adverse effects such as hypotension, hypoxemia, arrhythmia, cardiac arrest, cardiopulmonary dysfunction, and even death