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Previously, I blogged about the Nov. 28, 2018 recall of Stryker’s Tritanium posterior lumbar (PL) cage. The cage was recalled after reports of cage fractures occurring during and after surgical implantation, putting patients at-risk for a number of medical complications.  The surgical technique is being updated to caution against misuse due to the reports of cage fractures occurring intra-operatively and post- operatively. The recall of the device does not implicate a manufacturing design, rather, that the surgical technique is being updated to caution against cage misuse by surgeons.

The PL cage is made of Tritanium, Stryker’s propriety titanium alloy material that is built by using Laser Rapid Manufacturing. The PL cage is a unique configuration of solid and porous surfaces, which allows a spinal fusion to take place. Bone graft is placed inside of the hollow cage then placed so a spinal fusion occurs between vertebrates. It is used in two types of spinal procedures: posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF).

Minimally invasive TLIF and PLIF procedures are performed to relieve pressure on spinal nerves and cord, and to stabilize the spine. They are often performed on patients with lower back pain associated with conditions such as degenerative disc disease, herniated disc, spondylolisthesis, and spinal stenosis.

What Health Risks Can Arise from Stryker PL Cage Complications?  

According to the U.S. Food & Drug Administration, “the surgical technique [of the Stryker PL cage] is being updated to caution against misuse due to reports of cage fractures occurring intraoperatively and postoperatively.” Stryker’s PL cages are not meant to withstand the same level of activity that a healthy bone can, which can lead to the cage loosening, bending, or fracturing.

In some cases, surgeons implant cages inappropriately or in an improper place. This can result in inadequate bone fusion, fissure, fracture, or perforation of the same. When this happens, the PL cage needs to be removed or corrected immediately to prevent permanent damage.

The Tritanium PL cage was issued under a Class II recall, which indicates an intermediate level of threat to patients. In the words of the FDA, a Class II recall is “a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible health consequences or where the probability of serious adverse health consequences is remote.” So, although PL cage users may not be facing an immediate health hazard or threat of serious injury, the risk is still present.

There are several identifiable immediate and long-term risks associated with the surgical implantation of the Tritanium PL cage. This includes:

  • Loss of proper spinal curvature
  • Delayed union or non-union
  • Neurological and spinal dura mater lesions
  • Inflammation
  • Paralysis
  • Complications caused by instrument failure
  • Allergic reaction
  • Decrease in bone density
  • Dural leak that requires a surgical repair
  • Peripheral neuropathies
  • Heterotopic bone formation
  • Loss of power or bladder function

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.

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