On Nov. 28, 2018, Stryker recalled its Tritanium posterior lumbar (PL) cage. Stryker’s reason for doing so, according to the FDA’s website, is that “the surgical technique is being updated to caution against misuse due to reports of cage fractures occurring intraoperatively and postoperatively.” In other words, pieces of the PL cage are fracturing during and after surgical implantation, which puts patients at risk for medical complications.
The Tritanium PL cage is a rectangular, hollow medical implant that is used in two types of spinal fusion procedures: the posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF). Bone graft is placed inside of the hollow cage, which is then put in place to allow a spinal fusion to occur between two vertebrate. It is designed to make spinal fusion procedures open and minimally invasive, which can promote an easier recovery.
It is important to know that these implants cannot indefinitely withstand activity levels the way a healthy bone can. If the implant is subjected to excessive or repetitive stress, such as in patients with delayed or no healing, it can loosen, bend, or fracture. If this happens, the PL cage needs to be removed or corrected immediately to prevent further damage.
If a surgeon implants the cage in an inappropriate or improper place, it can deteriorate quickly and cause inadequate bone fusion. Failure to properly implant the components can also lead to fissure, fracture, or perforation of the spine after surgery. Revision or reoperation surgery is often necessary when this happens.
The Tritanium PL cage was issued under a Class II recall, indicating an intermediate level of threat to patients. This means that while users may not be facing immediate death or injury, the risk is still present.
Our law firm of Childers, Schlueter & Smith is well-versed in drug and medical device litigation and might be able to help you or a family member who is suffering due to a defective or fractured Tritanium posterior lumbar cage. If you have questions, please give us a call at 800-641-0098. All initial inquiries are free of charge and without obligation.
A partner with Childers, Schlueter & Smith, LLC, Richard Schlueter has spent his career representing individuals and families who have been harmed as the result of wrongful conduct by others. Recently, Richard was selected for inclusion into the Nation’s Top 1 percent of lawyers by the National Association of Distinguished Counsel (NADC).