Patient sickened by tainted spine allograft sues Aziyo, Medtronic

Carly Behm -   Print  |
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A Delaware man is suing Aziyo Biologics and Medtronic alleging he was infected with tuberculosis after receiving an infected spine allograft, which was produced and distributed by the two companies.

Richard Williams had cervical spine surgery on April 13 during which FiberCel from a recalled lot was implanted, according to a lawsuit filed June 16 in Delaware's Superior Court. His surgical wound tested positive for tuberculosis and was caused by a contaminated FiberCel implant, according to the complaint.

Mr. Williams had to undergo a revision surgery June 7 to remove the FiberCel product and insert a new bone product. During that surgery, his spine was fused at another level, decreasing his range of motion.

He is seeking a trial by jury and damages.

Aziyo Biologics on June 2 voluntarily recalled a lot of its FiberCel product after receiving reports of patients testing positive for tuberculosis. Aziyo Biologics didn't immediately respond to requests for comment on June 17.

Although the lawsuit was filed, it hasn't been served yet, Medtronic's Director of Corporate Communications Ben Petok said in an email to Becker's Spine Review.

"In coordination with Aziyo, Medtronic is working closely with the FDA and CDC to urgently notify healthcare providers and their patients about the impacted lot of FiberCel VBM and ensure healthcare providers have the necessary guidance to manage the care and treatment of their patients," he said. "Medtronic is also working to develop a patient support program in coordination with Aziyo and the CDC."

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