Patients Contract Tuberculosis Resulting in Allograft Recall

Silver Spring, MD (WorkersCompensation.com) – Earlier this month, Aziyo Biologics issued a voluntary recall of a specific lot of their bone matrix allograft FiberCel which is sold exclusively through Medtronic.  FiberCel is a bone repair product made from human donor tissue that is often used in orthopedic and spinal surgeries. The lot that was recalled included 154 allografts from a single donor, and were shipped to 37 facilities in 20 states between March 3rd and April 2nd.

According to a press release, the recall occurred when the company learned of infections, including some cases of tuberculosis, in patients that had received the FiberCel allografts. As a precaution, the company ceased shipments of Fibercel, and at the time of the press release, it was believed that no other allografts from other donors were impacted.

According to a recent Becker’s report, 91 patients who received the lot of allografts in surgery have had to undergo treatment for tuberculosis. One of the patients, a retired corrections officer from Delaware, who contracted tuberculosis after receiving the infected allograft in a cervical spine procedure, has filed a lawsuit against Aziyo and Medtronic, and has had to undergo a revision surgery to have the allograft removed, resulting in more complications.

In Indiana, three more lawsuits alleging negligence have been filed by the Wagner Reese law firm, according to a report from The Herald Times. In one of the cases involving a spinal fusion and cyst removal, the patient claims that they were told they would receive hardware implants and had no knowledge of any implanted donor tissue.

An additional point of interest that the Wagner Reese case presents is that while Aziyo has included a statement regarding the potential for infectious diseases such as hepatitis or HIV, there is no specific warning regarding tuberculosis.

The CDC has issued a statement and guidelines for physicians with patients receved the infected grafts.

While screening practices have improved over the years, infected donor tissue is still a potential issue, especially for orthopedic patients. One 2008 study found that 96.5 percent of allograft recalls involved musculoskeletal tissue. However, there has been some discussion in other areas of medicine of potentially considering the use of infected donor organs in an effort to meet demand for transplants. Hepatitis is one of the most common blood born infections in conjunction with drug overdose deaths. In 2019, 6.6 percent of all donor organs were positive for Hepatitis C.

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