If you or a loved one recently underwent a Synex II Vertebral Body Replacement surgery and later experienced adverse effects, you may be eligible to file a lawsuit for money damages. These devices are affected by the Class 1 Vertebral Body Replacement Recall. Learn more about the device’s Creep mechanism and NuVasive X-Core.
Class 1 Vertebral Body Replacement
A recall has been issued by the FDA for all lots of Synthes USA Ti Synex II vertebral body replacement, which was distributed between July 2, 2007, and Sept. 8, 2009. Those who have received the implant may have experienced nerve injury, increased pain, and spinal compression fracture. A Class 1 recall means that there is a reasonable risk of an adverse health effect. If you have had the implant, contact your surgeon for more information.
The device uses a titanium alloy to support vertebral bodies that were fractured by surgery or trauma. The titanium implant is an expandable titanium device that is designed to support weight heavier than it can handle. The company has issued a Class 1 recall. To address the recall, the company has worked with the FDA to design a new version of the device. Among the changes made to the device is its increased risk of infection.
The titanium Creep mechanism in a Ti Synex II vertebral body replacement enables surgeons to implant a new device at the same time as restoring bone height and providing immediate biomechanic spinal stability. This new technology is useful for patients who have undergone vertebral body fracture, especially those with osteoporotic or traumatic vertebral bodies. Unlike the previous Synex devices, Ti Synex II uses a proprietary Creep mechanism to prevent the artificial bone from slipping.
The implant was positioned anteriorly to the spine. Once in place, it was distracted to ensure optimal contact with the adjacent end-plates and minimize the risk of secondary dislocation. Compared to a Ventrofix or Harms cage, the Ti Synex is more efficient at stabilizing vertebral bodies. There are many advantages of using this implant over other artificial implants.
X-Core Mini device
In the wake of the FDA Ti Synex II vertebral body replacement implant recall, patients and their families may seek compensation for their faulty device. The Class I recall was issued on Sept. 8 and affects all lots of the devices. The device is intended to replace a damaged or collapsed vertebral body. Patients have reported problems with the implant, including loss of height, increased pain, and spinal kyphosis. Additionally, failure of additional fixation may cause complications, including spinal kyphosis, nerve injury, and the need for additional surgery.
The X-Core Mini is not affected by the recall. The device is also known as FBC)-m1kyC-m1CN%D. The company is also appealing the lawsuit. In the meantime, patients should be aware of the product’s safety record. The X-Core Mini is part of a Ti Synex II vertebral body replacement recall lawsuit.
NuVasive X-Core device
NuVasive received a 510(k) clearance for the X-Core spinal implant in the Ti Synex II vertebral body replacement lawsuit and is liable for $1 million in damages. The company was interested in acquiring Trilliant’s surgical data analytics platform. On June 24, NuVasive signed a five-year deal to gain access to the data analytics platform and agreed to pay the company $253,300 per year.
The faulty implant was made of a composite material with an alloy composed of aluminum and a ceramic composite. The alloy used is referred to as “Ti-Gr3”. It is equivalent to “Wl1YE6″ Cyk70M” and “YlTN8.F.” It is unknown what the composition of this alloy is, but the product was recalled for three years.
1 thought on “Ti Synex II Vertebral Body Replacement Recall Lawsuit”
Was wondering if this lawsuit is still on going. I had Ti Synex ll implanted on 7-28-2008 and didn’t get the recall letter from surgeon until 5-5-2010. I had more pain for years.