Federal and state health officials are investigating a rare tuberculosis outbreak among more than 100 patients who may have been infected after having spinal surgery or fracture repairs this spring with a bone product contaminated with the bacteria that causes TB.
The product, made by Aziyo Biologics Inc., a regenerative medicine company, came from a single donor, or cadaver, the company said.
Of the total, 136 were implanted into 113 patients, according to CDC officials. Eight patients died after their procedures, but the cause of death is still being determined, CDC spokeswoman Martha Sharan said Thursday.
Aziyo said in a statement it is “continuing to collaborate with FDA and the CDC on an investigation into the matter and at the appropriate time, we will provide more information.”
In the meantime, public health officials are recommending that the remaining patients who received these bone repair products be treated for tuberculosis even if they are not showing symptoms. Health-care providers are contacting 105 patients who used this product and all but four are being treated for the disease, the CDC said in a statement Thursday.
States were able to sequester 18 of the affected products to prevent additional surgeries, the CDC said. The agency is investigating the outbreak with state health departments, the Food and Drug Administration and the companies that manufactured and distributed the product.