The CD Horizon Spinal System was recalled less than a year after it was approved by the FDA, as it was found prone to failure — which included cable breaks leading to new pain in the back and legs, as well as the need for removal or replacement surgery.
Manufactured by Medtronic Sofamor Danek USA, Inc., the CD Horizon Agile Dynamic Stabilization Device (also known as the CD Horizon Spinal System) consists of a variety of rods, hooks, screws, plates, cables and spacers that come in a variety of different sizes and shapes. These components can be locked in a variety of different ways, so each system can be custom-made for each patient. The CD Horizon Spinal System is surgically attached to the spine to alleviate back and leg pain in patients with scoliosis or other pre-existing degenerative spinal conditions. Its goal is to provide stability to the spine, while also allowing the spine to have natural movement.
Unfortunately, within a year of the product being approved by the FDA, cable components of the CD Horizon Spinal System were found to be prone to failure. The cables broke, causing new and often extreme back pain in patients. As a result, Medtronic recalled its CD Horizon Spinal Systems because of shear failure of the cable component of the system.
It is unknown exactly how many CD Horizon Spinal Systems are on the market, but there could be as many as 200,000, as they were distributed worldwide.
Due to the severity of the symptoms associated with the CD Horizon Spinal System failure, CD Horizon Spinal System patients may want to contact a CD Horizon Spinal System lawyer at The Schmidt Firm, PLLC to discuss the potential of a CD Horizon Spinal System lawsuit.
Symptoms of a CD Horizon Spinal System Malfunction
When a traumatic event, such as a fall, creates a breakage in the cable of the CD Horizon Spinal System, it can lead to side effects including the following:
- Return of pre-surgical symptoms
- Leg pain
- Back pain
- Irritation of tissue due to displaced components
- Degeneration of the spine
- Additional surgery (often to remove or replace the CD Horizon Spinal System)
How the CD Horizon Spinal System Works
The CD Horizon Spinal System is used to create spinal fusion, whereby spin screws or rods are implanted into the spine in order to keep vertebrae welded together. These implants are joined together to restore stability to the spine, while also allowing for the natural movement of the back. Commonly, the process is used to correct deformities, like spinal fixation or scoliosis, or damaged parts of the spine.
FDA Approval and Recall
All medical products must have FDA approval before they may be sold. However, as regulations currently stand, medical devices like the CD Horizon Spinal System can be approved by the FDA without ever being tested in patients. Any product that is similar to an already existing product currently on the market may be pre-approved as part of the 510(k) model. Manufacturers prefer this approval system because it is cheaper and takes less time. As the CD Horizon Spinal System resembles previous products on the market, it was pre-approved.
In a January 18, 2007 approval letter from the FDA to Medtronic, the FDA Director of the Division of General, Restorative and Neurological Devices writes:
“We determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug and Cosmet Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device.”
Unfortunately, without having undergone the necessary pre-testing, the FDA was unaware of the possible break failure in the the cable components, which caused unnecessary harm to patients.
When the product was found to fail, it prompted a quick recall by both the manufacturer and the FDA. Less than 12 months after receiving their product approval letter, Medtronic Sofamor Danek USA, Inc. sent out a letter on December 12, 2007 to hospitals and surgeons that had used the CD Horizon Spinal System implants. The letter notified healthcare professionals of a recall due to breaks. The letter recommended surgeons follow-up with and monitor patients who had received the device.
The recall was then posted by the FDA on September 11, 2008.
Sadly, for the 11 months the device was available on the market, patients who received the implant were subjected to unnecessary additional pain in their back or legs — often requiring additional surgery — because of the unknown risk of component breakage.