Synthes Side Effects and Complications – Vertebral Height Collapse – Synex II
Synex II vertebral body replacement device is a sophisticated surgical technology designed to replace damaged vertebrae. Manufactured by Synthes, the device was marketed under the brand name Ti Synex II Central Body Replacement from July, 2007 to September, 2009. While initial patient feedback was positive, alarming news about dangerous Synex II complications emerged in 2009. At least six patients reported that their vertebral replacements had decreased in height or collapsed within the spine, causing severe pain and spinal instability.
Synthes FDA Recall
In response to patient reports, the FDA issued a Class I recall of Synthes vertebral replacement devices on November 12, 2009. The agency asked surgeons to stop using Synex II vertebral replacements immediately and to carefully monitor patients implanted with these devices. The FDA underscored the seriousness of the problem by classifying the Synthes recall as Class I recall. This is the strongest recall that the FDA issues when the recalled product poses a high risk of serious injury or death.
Synex II Vertebral Body Replacement Side Effects
Although the body of the Synex II vertebral replacement device is made of titanium, it might be prone to collapse and reduction in height. Even a seemingly minor loss of height can cause serious problems as it destabilizes the vertebral and compromises the structural integrity of the spine. Some of the more common Synthes vertebral body replacement complications include:
Pain. When the artificial vertebral body is reduced in height, it might become misaligned, pressing on the spinal nerves and bones. Depending on the extent of the problem, the patient might experience pain ranging from moderate tingling to excruciating hurt.
Neural Damage. If the malfunctioning of the Synex II vertebral body replacement is not discovered early, the spinal misalignment can lead to permanent nerve damage.
Spinal Kyphosis. This condition occurs when the spinal cord develops an abnormal curve. A malfunctioning vertebral implant might cause the weight distribution and spinal alignment to shift in order to relieve pressure from the malfunctioning vertebral. If this abnormal spinal alignment persists, it might permanently alter the curves of the spine.
Failure of Supplementary Fixation. One of the more serious Synex II vertebral replacement side effects is failure of supplementary fixation. This event can occur because the vertebral replacement is not used as a stand-alone device but together with other spinal fixation devices, such as a more traditional screws-and-rods system. If the artificial vertebral loses its original height or collapses, the stability of the inter-linked supplementary system might also become compromised.
Additional Surgery. Depending on the extent of Synthes vertebral replacement malfunction, a revision surgery might be required to correct the problem. In some cases, the surgeon might have to remove the Synex II vertebral body replacement and insert a different spinal fixation device. As all surgeries, revision Synthes procedure carries the risks of adverse reaction to anesthesia, infection and difficult recovery.
Signs of Synthes Vertebral Body Replacement Side Effects
The early warning signs of Synex II vertebral body replacement complications include tingling sensation in the back. Depending on the location of the implant, the tingling sensation might extend to the arms and legs. The pain might increase slowly over time or it might develop rapidly and become severe. Other signs of vertebral replacement malfunction include decreased range of motion, spinal compression and changes in the spinal curve. Patients with these symptoms should consult their physicians as surgery might be necessary to avoid permanent spinal damage.
Because the manufacturers of medical devices have a duty to provide consumers with reasonably safe products, they might be liable for failure to adhere to this responsibility. If you have suffered serious Synthes vertebral body replacement side effects, you might be entitled to compensation for your physical, emotional and financial damages. Please contact us to schedule a consultation with a skilled Synthes lawyer who will evaluate your case, explain your rights and help you select the most appropriate plan of action.