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Florida Couple Sues Major Medical Device Manufacturer Over Defective Surgical Implant Recalled by FDA

By: Anapol Weiss

Oct 7, 2025

PHILADELPHIA, PA, October 7, 2025 — The law firm Anapol Weiss has filed a product liability lawsuit in the U.S. District Court for the District of New Jersey on behalf of Connie and James Sprague of Florida against Medtronic, Inc., Medtronic USA, Inc., and Integra LifeSciences Corporation.

The complaint alleges that a defective neurosurgical implant, the Durepair Dura Regeneration Matrix, caused severe injuries following Ms. Sprague’s 2022 brain surgery to remove a meningioma, a tumor affecting the brain’s protective membranes. The device, a medical implant used to replace the hole in the dura surrounding her brain following her surgery, was recalled by the FDA in June 2023 after higher-than-normal endotoxin levels were found at Integra’s Boston manufacturing facility, affecting over 65,000 units worldwide.

According to the lawsuit, the recalled implant eroded after implantation, leaving part of Ms. Sprague’s brain exposed and requiring multiple corrective surgeries. The symptoms presented as a post-operative infection, and it was only after receiving news of the recall that Ms. Sprague learned the cause of her problems. She continues to experience neurological complications, including headaches, dizziness, and cognitive issues.

“This case underscores the devastating consequences that occur when manufacturers prioritize production over patient safety,” said Kila Baldwin, lead counsel at Anapol Weiss.

The lawsuit alleges negligence and manufacturing defect, and seeks both compensatory and punitive damages.

About Anapol Weiss: Anapol Weiss, a majority-women-owned law firm based in Philadelphia, represents clients nationwide in complex product liability and medical device litigation. To learn more, visit www.anapolweiss.com.

Media Contact: Samantha Kessler, Esquire Digital
1-866-ESQUIRE | samantha@esquiredigital.com www.esquiredigital.com

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Anapol Weiss

Anapol Weiss is a top-rated national personal injury firm with a reputation for winning big. Our trial attorneys are leaders in medical malpractice, women's health litigation, personal injury, and mass torts cases. As a female majority-owned firm with a deep bench of experienced, determined trial attorneys, we are compassionate with our clients and fierce in the courtroom.