IMPORTANT SAFETY INFORMATION SPINAL SURGICAL ROBOTICS

ROBOTICALLY ASSISTED SPINE SURGERY

Serious complications may occur with any surgery, including Mazor X™ Robotic Guidance Platform surgery, up to and including death. In addition, there are risks that are specific to certain surgical procedures. Also, some medical conditions can increase the risks of any surgery. Patients should discuss pertinent surgical risks with their doctors.

This document provides a summary of the risks associated. Primary risks include infection, device components breaking during use, use by unqualified personnel, and inflammatory reaction to the instruments.

RISKS AND POTENTIAL COMPLICATIONS OF SPINE SURGERY

DURING SURGERY

• Loss of a large amount of blood (blood transfusion needed)
• Any inadvertent cut, tear, puncture, burn or injury to organ, structure, or tissue, including, but not limited to:
  • Major blood vessel
  • Hollow organ, such as the bowel or bladder
  • Solid organ, such as the spleen, kidney, heart, lungs, or liver
  • Ureter (tubes that carry urine from the kidneys to the bladder)
  • Nerves
• Loss of a piece of an instrument, particulate or any other object used during surgery in patient’s body
• Anesthesia risks (anesthesia is medicine that allows patients to sleep deeply and not feel pain during surgery): heart attack, stroke, blood clotting deep in the body, blocked lung artery, pneumonia (serious lung infection), dental injury, injury to the vocal cord and death
• Patient positioning injury: hemodynamic, intraocular pressure, neurologic, soft tissue injuries

AFTER SURGERY

The complications listed below may go away on their own, with standard treatment from a doctor, or may require: medicine, radiological intervention (allows doctors to see inside your body with imaging such as X-rays, CT or MRI scans or ultrasound), admission back into the hospital, extended hospital stay, and/or another operation.

• Early or late loosening of any or all of the components
• Disassembly, bending, and/or breakage of any or all of the components
• Foreign body (allergic) reaction to implants, debris, corrosion products (from crevice, fretting, and/or general corrosion), including metallosis, staining, tumor formation, and/or autoimmune disease
• Pressure on the skin from component parts in patients with inadequate tissue coverage over the implant possibly causing skin penetration, irritation, fibrosis, necrosis, and/or pain. Bursitis. Tissue or nerve damage caused by improper positioning and placement of implants or instruments
• Post-operative change in spinal curvature, loss of correction, height, and/or reduction
• Infection
• Dural tears, pseudomeningocele, fistula, persistent CSF leakage, meningitis
• Loss of neurological function (e.g., sensory and/or motor), including paralysis (complete or incomplete), dysesthesias, hyperesthesia, anesthesia, paresthesia, appearance of radiculopathy, and/or the development or continuation of pain, numbness, neuroma, spasms, sensory loss, tingling sensation, and/or visual deficits
• Neuropathy, neurological deficits (transient or permanent), paraplegia, paraparesis, reflex deficits, irritation, arachnoiditis, and/or muscle loss
• Urinary retention or loss of bladder control or other types of urological system compromise
• Scar formation possibly causing neurological compromise or compression around nerves and/or pain
• Fracture, microfracture, resorption, damage, or penetration of any spinal bone (including the sacrum, pedicles, and/or vertebral body) and/or bone graft or bone graft harvest site at, above, and/or below the level of surgery. Retropulsed graft
• Herniated nucleus pulposus, disc disruption or degeneration at, above, or below the level of surgery
• Non-union (or pseudarthrosis), delayed union, mal-union
• Loss of or increase in spinal mobility or function
• Inability to perform the activities of daily living
• Bone loss or decrease in bone density, possibly caused by stresses shielding
• Graft donor site complications including pain, fracture, or wound healing problems
• Ileus, gastritis, bowel obstruction or loss of bowel control or other types of gastrointestinal system compromise
• Hemorrhage, hematoma, occlusion, seroma, edema, hypertension, embolism, stroke, excessive bleeding, phlebitis, wound necrosis, wound dehiscence, damage to blood vessels, or other types of cardiovascular system compromise
• Reproductive system compromise, including sterility, loss of consortium, and sexual dysfunction
• Development of respiratory problems, e.g., pulmonary embolism, atelectasis, bronchitis, pneumonia, etc
• Change in mental status
• Death

Note: Additional surgery may be necessary to correct some of these potential adverse events.