A total of 113 patients across several states may have contracted tuberculosis after having spinal surgery or fracture repairs involving a contaminated bone repair product, The Washington Post reported June 18. The CDC, FDA and state health departments are investigating the outbreak.
Eight patients died after their procedures involving the contaminated product, though the cause of death is still being determined.
The product, called FiberCel, is made by Aziyo Biologics and is distributed by Medtronic. It's a malleable bone putty made of human cells and is involved in a number of orthopedic procedures. Aziyo has recalled 154 containers of the product, which were shipped to 37 facilities across 20 states between March 3 and April 2, according to a CDC statement cited by the Post.
A total of 136 containers of FiberCel were implanted into 113 patients, and health officials are now recommending all who received the contaminated products be treated for TB, regardless of whether they are experiencing symptoms.
Indiana and Delaware have reported the most cases, the Post reports. In Indiana, health officials are monitoring 30 people who received the affected bone repair product, and in Delaware, 23 patients received the products.
Aziyo issued a voluntary recall for a single lot of the product June 2 after receiving a complaint of post-surgical infections in seven of 23 patients who received FiberCel from the lot at an unidentified hospital. Of those, seven patients tested positive for TB, the FDA said in its recall notice.
Since then, states have been able to sequester 18 of the contaminated products to prevent them from being used in additional procedures.
In a statement to the Post, Aziyo said it is "continuing to collaborate with FDA and CDC on investigation into the matter and at the appropriate time, [it] will provide more information." The company also said the affected product was derived from a single donor.
Beverly Bliss, vice president of accreditation and standards for the American Association of Tissue Banks, told the Post that since TB is extremely rare in bone grafts — with the last such case occurring in 1953 — testing for the bacteria that causes the infection isn't currently conducted. Human tissue implantation products are more commonly tested for HIV, hepatitis C and other diseases, she said.
A spokesperson for Medtronic, the product's distributor, told the news outlet that while it has quality controls in place, it does not test the product, adding that it has paused distribution until the investigation is complete.
At least one patient in Delaware, who underwent a spinal fusion April 13 at a ChristianaCare hospital that used the affected product, has filed a lawsuit against Aziyo and Medtronic.
To read the full Washington Post story, click here.