INVISx Cranial Fixation System

Indications, Safety, and Warnings

Warnings and Precautions

Improper fixation of INVISx™ Locks may result in formation of cranial ridges; changes in the position of the cranium and loosening and/or fracture of implant components. The use of a minimum of four INVISx Locks placed equidistantly is recommended for maximum stability. Refer to the section on Stem Placement. Do not place INVISx Locks over burr holes. Place only in kerf. It is advised that the surgeon be thoroughly familiar with the surgical techniques relative to the use of this device. The surgeon is responsible for proper application of the INVISx Cranial Fixation System. Complications due to incorrect diagnosis and operational technique are the responsibility of the surgeon.

Complications

General risks may include infections, nerve damage, hematomas and impairment of wound healing. The patient should be made aware of these risks and others associated with neurosurgery, general surgery and the use of anesthesia.

Important Safety Information

Attention Consumers!

This therapy is not for everyone. Please consult your physician. A prescription is required.

Attention Physicians!

For further information, please contact your Medtronic NT sales representative.

Caution: Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only. Refer to product package insert for instructions, warnings, precautions and complications.