What is a Synthes Vertebral Implant?

Synex II Vertebral Body Implant is a device used in the thoracic and lumbar spine (T1-L5) to replace a damaged, collapsed, or unstable bone in the spinal column body.¹ Simply put, this device is intended to assist the physician in repairing spinal columns that have been damaged due to the removal of tumors, or injury to the vertebrae such as fracture. The purpose of this device is to stabilize the spinal column, while providing the patient with an acceptable range of motion.²

Does it work?

A Class 1 recall for this product was initiated on September 14, 2009. Class 1 recalls are the most severe type of recall and involve conditions in which there is a chance that use of these products will cause unfavorable health outcomes or death.³

Patients reported cases where the implant failed due to collapse. In addition, patients who did not experience complete failure did report partial failure causing a loss of height. Even slight reductions in height in the spinal region can cause severe pain, neural damage and spinal curve.⁴

Patients possibly will require supplementary surgery in order to correct the vertebral appliance or replace it with a different device.

Let your Doctor know if you…

If you have this implant, or uncertain of the implant you received during back surgery, you should contact your surgeon with any questions. The product was in use from July 2, 2007 through September 8, 2009.⁵ It was distributed under the name Ti Synex II Central Body Replacement.

Should you start to experience a tingling sensation in your back, arms or legs contact your physician as these are considered the early warning symptoms of a problem with your implant.⁶

Further, if you are experiencing pain, or have had additional surgery to repair or replace your implant you may be compensated for your expenses. If you fall in this category, you should consult with an attorney.

In addition, you may call Synthes, (the manufacturer) with questions and concerns at:
Phone: 1-800-752-0128, 8:30 a.m. – 4:30 p.m., Monday through Friday, Eastern Time, or
Email: ComplaintUnit@synthes.com

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¹ http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190330.htm
² http://www.mediafact.com/synthes-recall/synex.html
³ http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm190300.htm
⁴ http://www.classaction.org/ti-synex-ii-vertebral-body-replacement-recall.html
⁵ http://www.transworldnews.com/NewsStory.aspx?id=156057&cat=10
⁶ http://www.mediafact.com/synthes-recall/synex-side-effects.html