FiberCel is a fiber-based bone repair product manufactured by Aziyo and distributed in the U.S. by Medtronic. It is made from human tissue and engineered to maintain characteristics of natural tissue.  FiberCel is used in orthopedic or reconstructive bone grafting procedures in combination with autologous or allograft bone, or alone as a bone graft. (Autologous bone is the patient’s own bone whereas allograft bone comes from a donor.) 

Tuberculosis is a serious, communicable disease caused by a bacterium called mycobacterium tuberculosis. It can be life-changing and life-threatening, particularly in vulnerable patients such as those recovering from surgery. TB is also highly communicable therefore all TB infections must be reported to the local or state health department tuberculosis program. 

The potential contamination of Aziyo’s FiberCel product was only made public in June 2021. On June 2, Aziyo issued an urgent voluntary notification recalling one lot (Donor Lot No. NMDS210011) of Fibercel in response to a customer complaint. A hospital had reported post-surgical infection in 7 of 23 patients that received FiberCel from this lot, four of whom tested positive for TB. According to Aziyo, the contaminated material came from one single donor, and was distributed in 154 units to 20 states across the country. The recall instructed all hospitals that had received Fibercel from this lot to immediately quarantine and return any unused product. According to a June 7, 2021 press release, Aziyo has now suspended all distribution of FiberCel, and, together with the U.S. Centers for Disease Control and Prevention (CDC,) is investigating the source of the contamination. 

Richard Williams was implanted with FiberCel from the contaminated lot during spinal fusion surgery in April 2021. Mr. Williams, the plaintiff in this first lawsuit, was a patient at Christiana Care in Delaware who developed a post-operative infection and tested positive for TB. As a result of this, he had to have revision surgery on June 7, 2021 to remove the contaminated FiberCel and redo his spinal fusion, and now requires ongoing medical care and monitoring for TB. The success of his underlying cervical spinal procedure was also affected because the revision surgery required his spine to be fused at a higher level resulting in decreased range of motion and more substantial permanent injury. 

The extent of the FiberCel contamination and its impact is not yet known. Mr. Williams is just one patient. Even at this early stage, Aziyo has admitted that the known contaminated FiberCel lot was distributed in 154 units to 20 states. It is fully expected that there are more injured victims out there, and that more lawsuits will follow. Aziyo also appears to be braced for future litigation, having suspended its recent revenue guidance for 2021 due to “the uncertainty regarding any potential impact to Aziyo’s business resulting from the recall and the pause in FiberCel sales.”