Spinal fusion is a surgery that permanently joins bones in the spine (“vertebrae”). Unfortunately, many people have been seriously injured by defective medical devices that are used in this procedure. Many lawsuits have been filed against manufacturers of these products, including Medtronic.
What is Spinal Fusion?
Spinal fusion is a type of surgery that fuses two or more bones in the spine (called “vertebrae”) into one solid bone. This surgery is necessary when the spine is not capable of supporting normal loads and stresses due to injury or disease. Surgery is usually necessary when external fixation (braces or physical therapy, for example) are not enough to maintain alignment of the spine.
During spinal fusion surgery, intervertebral discs made of cartilage are removed and metal devices are implanted to stabilize the spine. In the past, doctors also implanted bone grafts that were harvested from cadaver’s or the patient’s hip bone. In recent years, companies have developed bio-engineered bone growth proteins that may also be used to help encourage fusion. Surgeons may also attach metal plates and/or rods to the vertebrae using bone screws, wire, and hooks. Spinal implants may be temporary or permanent.
Spinal fusion is a treatment for spinal injuries, including acute trauma, herniated discs, bone fractures, and more. It is also used to treat chronic diseases, such as degenerative disc disease, back pain, nerve damage, scoliosis, spinal stenosis, tumors, and more.
FDA Warning for Bone Graft Substitutes in Children
January 21, 2014 — The FDA has issued a Safety Warning against the use of bone graft substitutes in children due to increased health risks. One of the most popular products, Medtronic Infuse, contains recombinant proteins that stimulate bone-growth.
Health officials are concerned that children may be at greater risk of nerve damage, chronic pain, weakness, and other complications due to their smaller size and growing skeleton. In 2012, a study found that 10% of spinal fusion surgeries in children used bone-growth proteins. Click here to read more.
Spinal Fusion Injuries, Complications, and Risks
- Defective or broken spinal implants
- Chronic pain
- Incomplete spinal fusion
- Surgery may not correct health problems
- Swelling (especially in the neck)
- Blood clots
- Nerve damage
- Spinal cord damage
- Sexual dysfunction
- Retrograde ejaculation
- Complications of anesthesia
- And more
Cardiff Anterior Cervical Plate System Problems
The Cardiff Anterior Cervical Plate System, also known as the “ACP System,” is a metal plate that is screwed into a patient’s spine to stabilize the area after a spinal fusion surgery. Unfortunately, early versions of the product were recalled in April 2010 after the manufacturer, SeaSpine, and the FDA received at least 13 adverse event reports.
Cardiff ACP System complications can include:
- Bone screws backing out
- Locking mechanism may not lock properly or sit naturally in the locking position
- Screw variability
- Clips may bend or break during functionality testing
- Bone screw angulation
- And more