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CDC, FDA investigating rare tuberculosis outbreak potentially linked to contaminated bone repair product - Fox News
Jun 21, 2021 1 min, 25 secs

The Centers for Disease Control and Prevention, Food and Drug Administration and state and local health agencies are investigating the origin of a rare, multi-state tuberculosis outbreak after more than 100 patients may have been infected during spinal surgery or fracture repairs this past spring.

The procedures used a bone repair product called FiberCel Fiber Viable Bone Matrix, a malleable bone putty developed by regenerative medicine company Aziyo Biologics which uses human cells and is used in a variety of orthopedic procedures, according to the Washington Post.

The Post reported that a total of 113 patients received the recalled product, with eight patients dying after their procedures, though the cause of death is still being determined.

The CDC warned in a statement that patients who underwent spinal fusions or fracture repairs using the recalled lot of FiberCel are "likely to have been exposed to mycobacterium tuberculosis", which can cause severe disease and death if untreated.

The agency is recommending that surgeons should work with their respective health department's TB programs to immediately contact patients who underwent surgery using the recalled product.

Indiana state health officials are investigating 30 individuals in 19 counties who received the bone repair product.

In Delaware, 23 patients received the bone repair products, an anonymous source familiar with the investigation told the Post.

Fenimore told the outlet that state health officials received notification in late May from a healthcare system about a cluster of patients who developed tuberculosis after surgery 'involving a specific product.'.

The lawsuit states that after Aziyo's voluntary recall was issued, Williams had a second surgery to remove the contaminated product and insert new bone five days later. 

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