Synthes FDA Recall - Vertebral Body Replacement Side Effects - Synex II

Vertebral body replacement is an advanced surgical technology used to replace severely damaged vertebrae. The surgery is usually recommended for patients who have fractured their vertebrae as a result of various accidents, such as car crashes and slip-and-falls. In addition, vertebral replacement surgery is sometimes performed on older patients whose vertebrae have lost their structural integrity as a result of the natural aging process. Regardless of the cause of vertebral damage, the goal of vertebral body replacement procedure is to strengthen the spine, alleviate pain and improve the range of motion.

Vertebral Body Replacement Surgery

During vertebral replacement surgery, the damaged natural vertebral is removed and an artificial implant, such as Synex II vertebral body replacement, is inserted in the spinal cord. The implant consists of a perforated metal cylinder and two end plates. The device is secured within the spinal cord so as to improve stability and allow for a certain range of motion. The perforation in the cylinder might be used for placement of bone grafts in order to promote spinal cord integration and healing.

Synthes FDA Recall

Synthes is one of the leading medical companies specializing in developing and manufacturing spinal vertebral replacement devices. One of the company’s most successful products was marketed under the name Ti Synex II Central Body Replacement. The device was manufactured and sold in North America from July, 2007 to September, 2009. However, in the fall of 2009 FDA received six reports stating that the Synex II vertebral body replacement device had collapsed in the patients’ spines only several months after being implanted. The FDA responded to the alarming news by issuing a Class I recall of Synthes vertebral replacement products on November 12, 2009. This is called a Synthes FDA recall.

Class I recall is the strongest FDA recall and it requires immediate termination of distribution and use of all Synex II vertebral replacement products with part numbers 04.808.001 - 0111. The FDA recommends that physicians should carefully monitor patients implanted with Synex II replacements to detect any potential vertebral body replacement side effects early. Some of the warning signs of malfunctioning Synthes vertebral replacements include moderate to severe back pain and limited range of motion. If not treated promptly, a malfunctioning vertebral implant might lead to neural damage and development of abnormal spinal curve. Depending on the severity of the problem, treatment of a defective Synthes vertebral body replacement might require corrective surgery or a complete replacement of the device.

Consulting an Experienced Synthes Lawyer

If you suspect that your back pain might be caused by a defective Synex II vertebral body replacement, consult your physician to begin prompt treatment. You should also contact an experienced Synex lawyer as compensation might be available for your physical, emotional and financial damages. A skilled Synex attorney will carefully review you case to determine whether filing a Synthes lawsuit might be beneficial. Other possible solutions include a settlement and negotiations. However, every situation is unique, which is why only a one-on-one consultation with an experienced attorney can help you determine you legal options.