Synex II vertebral body replacement is an artificial vertebral body that is used to replace a damaged natural vertebral. The goal of the vertebral replacement surgery is to strengthen the spine, increase the range of motion, and reduce or eliminate pain. Synex II is manufactured by Synthes, one of the leading medical device companies in the world. After reports emerged that several of the Synthes vertebral body replacement devices had collapsed inside patients' spines, the FDA issued a Class I recall of Synex II on November 12, 2009.

Use of Synthes Vertebral Body Replacement

Synthes recommended that surgeons use Synex II vertebral body replacement to repair serious vertebral damage resulting from spinal tumors and vertebral fractures. Spinal tumors can affect various parts of the spinal cord. As the tumors progress, they destroy soft and hard spinal tissues and often cause severe pain. Depending on the disease and the overall health of the patient, surgical removal of the tumors might be necessary. Unfortunately, this procedure often requires removal of vital bone structures, resulting in compromised vertebrae and unstable spine. Synthes vertebral body replacement was often used in such situations to rebuild the vertebrae and improve the integrity of the spine.

Similarly, Synex II vertebral body replacement was used to restore severely fractured vertebrae. vertebral fractures usually occur as a result of serious injury, including car accidents and slip-and-fall incidents. During the procedure, the damaged vertebral body was removed and a perforated titanium cylinder was inserted in the spine. The device was anchored in the spinal cord with special surgical spikes. The goal of the device was to improve the integrity of the spine while allowing for a range of motion. Initial studies of Synthes vertebral body replacement device showed promising results with most patients reporting decreased or eliminated back pain and ability to perform all of their pre-injury activities.

Synthes Vertebral Body Replacement Side Effects

While the initial feedback from Synex II vertebral body replacement patients was positive, in 2009 several reports of serious Synthes complications emerged. As of September, Synthes had received information about six patients whose vertebral replacement devices had collapsed only months after being implanted. These developments prompted Synthes to send a warning letter to its sales representatives and hospitals worldwide. The company asked surgeons to immediately stop using Synthes vertebral body replacements due to the high risk of serious complications.

While the most serious side effect of the Synex II vertebral body replacement was a complete collapse, the device was also found to be prone to height reduction. Even a very small decrease in the height of a vertebral can compromise the overall spinal integrity and cause persistent pain. In addition, a malfunctioning vertebral replacement can lead to neural injury, severe pain, failure of supplementary fixation, and abnormal spinal curve. Patients might require additional surgery in order to correct the vertebral implant or replace it with a different surgical device.

Synthes FDA Recall

As an added measure of safety, the FDA issued a Class I recall of Synthes vertebral body replacement device on November 12, 2009. The recalled device is marketed under the brand name Ti Synex II Central Body Replacement, and the recall includes all lots with part numbers 04.808.001 - 0111. The Synex II vertebral replacement was distributed in the United States from July, 2007 to September, 2009, and was implanted in numerous patients.

Consulting with a Dedicated Synthes Lawyer

If you or your loved one has received the Synex II vertebral body replacement implicated in the Synthes FDA recall, you might be able to obtain compensation for your injuries. Please contact us for advice. Highly experienced Synex attorneys will treat you with the highest respect and compassion while using aggressive strategies to pursue justice you deserve.

 

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