The wife of an Indiana man who died of tuberculosis after receiving Aziyo Biologics' recalled allograft is suing the company.
Gregory Flinn, 73, had a spinal fusion on April 8, and the surgeon implanted Aziyo Biologics' FiberCel implant, according to a lawsuit filed in Marion Superior Court July 16. A few days after the surgery, Mr. Flinn started experiencing symptoms including a fever, back pain, weakness and fatigue.
He was admitted to the ICU May 14 as his condition worsened. He tested positive for tuberculosis May 19 and started treatment the same day. Mr. Flinn died from the infection May 23, according to court records.
Mrs. Flinn's lawsuit alleges Aziyo Biologics and Medtronic, which distributed the allograft, failed to adequately obtain and review donor medical history, test the product for contamination, issue a timely recall and warn consumers of the risk of tuberculosis infection.
Aziyo Biologics recalled a lot of its FiberCel implant June 2. Several lawsuits have been filed on behalf of patients who were sickened by the implant since then.
The contaminated FiberCel products were used in 113 patients in 37 facilities across 20 states, WBIW reported July 26. Most of those cases have been in Delaware and Indiana.
Aziyo Biologics declined to comment on the lawsuit.
A Medtronic spokesperson said the company and Aziyo are working with the FDA and CDC to "ensure healthcare providers have the necessary guidance to manage the care and treatment of their patients." It is also working to create a patient support program with Aziyo and the CDC.
Note: This article was updated 8:10 a.m. July 27 to include information from Medtronic.