The number of patients treated for tuberculosis after undergoing spine surgery with FiberCel, a bone matrix allograft, is growing.
Ninety-one individuals across the U.S. who received Aziyo Biologics' allograft underwent treatment for tuberculosis as of June 15, according to a Delaware Online report. The company issued a voluntary recall of FiberCel on June 2 after seven of 23 patients at a single hospital tested positive for tuberculosis.
Aziyo is investigating the incident and found an infected lot of 154 FiberCel units, all of which came from a single donor. The company issued a statement June 7 saying none of the other FiberCel lots appear to have been infected.
One of the patients who tested positive for tuberculosis, Richard Williams, sued Aziyo and its U.S. distributor, Medtronic, on June 16. Mr. Williams underwent revision surgery June 7 to remove the FiberCel product and fuse an additional level of the spine.