The Medtronic CD Horizon Agile Dynamic Stabilization Device was a surgically implanted device that provided spinal stability to patients with generative spinal conditions.
After less than one year on the market, Medtronic Sofamor Danek USA, Inc. recalled its CD Horizon Spinal System after it was found to be prone to failure — which included cable breaks, causing new back pain and the need for an additional removal or replacement surgery.
CD Horizon Spinal System: An Overview
Using a combination of screws, rods, hooks, plates and cables, the CD Horizon Agile Dynamic Stabilization Device (CD Horizon Spinal System) is designed to create spinal fusion when it is implanted. It’s supposed to restore stability to the spine and reduce back and leg pain, while also allowing for the natural movement of the back.
Most commonly, the CD Horizon Spinal System is used to treat patients with back deformities, like spinal fixation or scoliosis, or damaged parts of the spine. The differently sized and shaped components may be locked together in a variety of ways, allowing each CD Horizon Spinal System to be tailor-made to the patient.
Unfortunately, less than a year after the product was approved by the FDA, the cable component of the CD Horizon Spinal System was found to be prone to failure. When the cables broke, often as a result of a simple fall, it caused new and often extreme pain in patients. Medtronic recalled the device in December of 2007, stating problems with “shear failure of the cable component of the system.”
All the while, as many as 200,000 CD Horizon Spinal Systems may have been implanted in patients.
If you or somebody you knew received a CD Horizon Spinal System as part of a spinal corrective surgery, you may want to contact a CD Horizon Spinal System attorney or lawyer with The Clark Firm for a free consultation in order to discuss the potential of a CD Horizon Spinal System lawsuit.
Symptoms of a CD Horizon Spinal System Break in the Cable Component
If you experience any of the following symptoms, you may have a break in the cable component of the CD Horizon Spinal System, which may require the need for additional surgery — often to remove or replace the CD Horizon Spinal System:
- Return of pre-surgical symptoms
- New onset of leg pain
- New onset of back pain
- Irritation of tissue due to displaced components
- Degeneration of the spine
FDA Approval System and CD Horizon Spinal System Recall
It is illegal for any medical device to be sold without first being approved by the FDA. Therefore, each new product is evaluated by the FDA for safety and efficiency.
However, with the way the current approval system stands, a product need only prove that it is similar to a product already on the market and the new product does not have to undergo premarket testing on patients before becoming available to the public. This model, called the 510(k) process is ideal for manufacturers because it saves them the time and money it takes for the premarket trials before their product may be sold.
As the CD Horizon Spinal System resembles previous products already on the market, it was pre-approved by the FDA without requiring any premarket clinical trials.
In a January 18, 2007 approval letter from the FDA, the FDA Director of the Division of General, Restorative and Neurological Devices told Medtonic regading the CD Horizon Spinal System:
“We determined the device is substantially equivalent to legally marketed predicate devices marketed in commerce prior to May 28, 1976 . . . You may, therefore, market the device.”
Without the preclinical trials, unfortunately, the FDA was unaware of any risks associated with the CD Horizon Spinal System. Therefore, the product was released to the medical market and implanted in countless patients before the FDA became aware of the shear failure of the cable component. When the cables began to break, it caused unnecessary and often extreme pain in patients.
The cable breaks prompted a quick recall by Medtronic, which released a letter to customers on December 12, 2007, notifying healthcare professionals about the recall. The letter was sent to surgeons, sales representatives and risk managers. Sales representatives were encouraged to follow-up with their respective surgeons who had implanted the product to verify their surgeon received the communication of the recall and that they were aware that patient monitoring is recommended.
The recall was then posted to the FDA Web site on September 11, 2008.
CD Horizon Spinal System Repairs
CD Horizon Spinal Systems made attempts to surgically correct generative spinal conditions, back deformities or damaged parts of the spine. Examples of conditions treated by the CD Horizon Spinal System include:
- herniated discs
- lumbar spinal stenosis
- degenerated discs