Ohio ASC patient among 110+ who received TB-infected spine device

A patient at the Cincinnati-based Mayfield Spine Surgery Center was one of the more that 110 patients who received a procedure with a tuberculosis-infected allograft, the Ohio Department of Health confirmed. 

The Ohio Department of Health confirmed that six Ohio residents had surgery with an infected allograft, and one of whom died.

Five units of the infected Aziyo Biologics' FiberCel allograft were sent to the Mayfield Spine Surgery Center, Dayton-based Miami Valley Hospital North and Cuyahoga Falls-based Western Reserve Hospital. 

Aziyo Biologics recalled a 155-unit lot of its FiberCel on June 2. The infected lot was from a single donor and was distributed to facilities in 20 states. 

“We cannot speak to a specific situation, however we take patient safety very seriously, and are committed to providing the highest level of quality care and experience for our patients," Mayfield Spine Surgery Center said in a statement to ABC affiliate News 5 Cleveland.

Miami Valley Hospital North didn't respond to the station's request for comment. Western Reserve Hospital told the station that one patient received the allograft a month before it was recalled. 

Aziyo Biologics said in a statement to News 5 that it is reviewing its procedure for screening donors and is working with the FDA and CDC in its investigation.

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Webinars

Featured Whitepapers

Featured Podcast