Pedicle Screw Lawsuit Claims Medtronic Voyager Spinal Implants Fractured After Fusion Surgery

Lawsuit claims that after surgeons removed a fractured Medtronic Voyager screw in early 2022 and implanted a replacement, the new device also failed within months.

A Florida man has filed a product liability lawsuit alleging that pedicle screws used during a spinal fusion surgery fractured inside his body, forcing him to undergo multiple operations after the implanted hardware failed.

The complaint (PDF) was brought by Darrell Travis Jr. in the Circuit Court for Leon County, Florida on December 17, and later removed to the U.S. District Court for the Northern District of Florida on January 20. It names Medtronic Inc. as the sole defendant.

Pedicle screws are small but strong metal screws that surgeons place into the bones of the spine, known as vertebrae. They are typically made from titanium or similar alloys and are designed to act as anchors, holding the spine in position while damaged or unstable segments heal. These screws are often connected by metal rods, creating a rigid support system that prevents movement in the affected area.

Doctors commonly use pedicle screws during spinal fusion surgery, a procedure intended to permanently join two or more vertebrae together. Spinal fusion is frequently performed to treat conditions such as degenerative disc disease, spinal stenosis, scoliosis, spondylolisthesis, herniated discs, or spinal instability caused by injury. By stopping motion between painful vertebrae, the surgery is meant to reduce nerve irritation and long-term pain.

During the procedure, surgeons insert the screws through the pedicle, a thick section of bone that connects the front and back parts of each vertebra. Once the screws are in place, rods are attached to keep the spine aligned while bone graft material slowly fuses the vertebrae together over several months. Patients are often told the screws are permanent and are expected to withstand everyday movements like walking, bending and sitting.

However if these devices should fail, the individual may require revision surgeries that carry increased risks of complications, infection and permanent impairment.

According to his lawsuit, Travis underwent spinal surgery at Capital Regional Medical Center in February 2020, during which surgeons implanted Medtronic Voyager pedicle screws as part of a laminectomy and fusion procedure. The devices were intended to stabilize the lower spine while the fusion healed.

A laminectomy and fusion procedure is a kind of spinal surgery that decompresses the spinal canal by removing the lamina, which is part of the vertebra, and other pressure points, like bone spurs, to relieve nerve compression. It then stabilizes the spine by fusing two or more vertebrae together with bone grafts, rods and screws to prevent instability and future issues.

Medtronic Pedicle Screw Problems

The complaint claims that follow-up imaging later revealed one of the pedicle screws had fractured, a problem that was not immediately communicated to Travis. When he returned for further evaluation in December 2021, he was reportedly informed that the screw at the S1 level had broken.

In January 2022, Travis allegedly underwent surgery to remove the fractured hardware. However, the lawsuit states that another Medtronic Voyager screw was implanted during that procedure. Just months later, in August 2022, imaging reportedly showed that the replacement screw had also fractured.

Travis claims he was forced to undergo yet another surgical procedure in September 2022 to remove the failed hardware, resulting in additional pain, recovery time and long-term complications.

The lawsuit alleges that the Medtronic Voyager pedicle screws were prone to fracturing after implantation, even when used as intended and implanted by qualified surgeons. Travis claims the screws were unreasonably dangerous due to design and manufacturing defects that made them susceptible to breakage under normal spinal loads.

According to the complaint, Medtronic failed to adequately test the screws, deviated from its own design specifications and did not provide sufficient warnings to surgeons about the risks of fracture, frequency of failure or potential consequences for patients.

The filing further claims that if adequate warnings had been offered, health care providers could have chosen alternative devices, different surgical techniques or closer monitoring, potentially avoiding the injuries Travis allegedly suffered.

“As a direct and proximate result of Defendant’s conduct and the defective condition of the Percutaneous Medtronic Voyager Screws, Plaintiff suffered and continues to suffer: past and future medical expenses; past and future pain and suffering; disability; physical impairment; disfigurement; mental anguish; inconvenience; loss of capacity for the enjoyment of life; lost wages; loss of earning capacity; and other economic and non-economic losses.”

— Darrell Travis Jr. v. Medtronic Inc.

The lawsuit raises allegations of strict product liability based on design defect, manufacturing defect and failure to warn, as well as negligence and breach of implied warranty. It is seeking damages for past and future medical expenses, pain and suffering, mental anguish, lost wages and diminished earning capacity.

More than a decade ago, the U.S. Food and Drug Administration (FDA) expressed concerns that certain newly manufactured pedicle screws may lead to future complications for patients. The agency indicated that it was requiring manufacturers to conduct post-market surveillance studies for existing systems, and premarket clinical trials for other systems currently under development.

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