CDC investigating TB cases linked to tainted bone repair product used in more than 100 patients - The Washington Post

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.

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.

The company said it received a complaint from an unidentified hospital that reported post-surgical infections in seven of 23 patients who received FiberCel from one lot of the product, according to the FDA’s urgent recall notification.

Aziyo said its voluntary recall was issued to hospitals that received product from the specific lot after the company learned of post-surgical infections in patients treated with FiberCel, “including some patients that tested positive for tuberculosis.”.

Indiana state health officials said they are working with local health departments and providers to investigate 30 individuals in 19 counties who received the bone repair product.

In Delaware, 23 patients received the bone repair products, according to an official familiar with the investigation, who spoke on the condition of anonymity because of the ongoing probe.

In late May, Delaware health officials received notification from a health-care system of a cluster of patients who developed tuberculosis after surgery “involving a specific product,” Delaware Division of Public Health spokeswoman Mary S.

Lawyers for Williams said the man received his diagnosis and learned that the product was contaminated before the official recall.

“We believe our client and likely others were infected with tuberculosis due to the contaminated surgical bone product which should have been fully tested to ensure it was disease-free and suitable for implantation,” Cohan said in a statement.

Shane Hoffman, a spokesperson for ChristianaCare, said in late May the health system identified “a small number of patients who tested positive for tuberculosis infection” following surgery involving a specific product.

Hoffman said the health system’s infection prevention team alerted patients, state health officials and the FDA, and is working with the state and the CDC to ensure patient safety.