An investigation by the CDC and the FDA published in The Lancet reveals new details about a tuberculosis outbreak stemming from spinal allografts.
The tissue donor was an 80-year-old man who had unrecognized risk factors, symptoms and signs of tuberculosis, the Aug. 4 report said. Bone was procured from him after he died and used in 154 units of allografts containing live cells.
Those units were distributed to 37 healthcare facilities across 20 states between March 1 and April 2, 2021. A total of 113 patients had those allografts implanted, and the remaining 18 were located and sequestered. Eight patients died within eight to 99 days of implantation, and three of those deaths happened after the outbreak was recognized.
The allografts were from Aziyo Biologics, and the company recalled the 154 units of FiberCel. Dozens of patients were treated, and some lawsuits were filed on behalf of patients who died after receiving the allograft.
The report supported laboratory testing for M tuberculosis and routine assessment of prospective donors for risk factors and clinical findings.