The Centers for Disease Control and Prevention is investigating a multi-state outbreak of tuberculosis in more than 100 spinal surgery patients who may have been exposed to TB bacteria through a contaminated bone repair putty.
On June 2, the biotech company Aziyo Biologics, Inc. issued an urgent recall notice for a single lot of its product FiberCel Fiber Viable Bone Matrix. The malleable bone repair putty is made from human tissue that is used in various orthopedic and spinal procedures.
The voluntary recall was issued after one hospital complained that 7 of the 23 patients that received FiberCel from a specific product lot developed post-surgery infections and four developed Tuberculosis, according to the U.S. Food and Drug Administration said. Hospitals in Virginia, Delaware, and Indiana have alerted the FDA to clusters of TB cases among spinal surgery patients.
Patients Harmed by FiberCel Have Legal Rights
Patients who have contracted Tuberculosis after spinal surgery or face additional surgery to remove the contaminated FiberCel bone putty have a legal right to hold the product manufacturer financially liable for the harm they have suffered. The patients may be due significant compensation. Those who have developed complications from a contaminated medical product should not be responsible for their medical bills. The manufacturer is legally responsible for ensuring its product is not contaminated.
Dr. Michael Wilson of The Law Offices of Dr. Michael M. Wilson MD, JD & Associates is a physician with a medical degree from Georgetown University as well as an attorney with more than three decades of legal experience. Dr. Wilson is well qualified to assist with a claim involving medical complications arising from a contaminated medical device. Schedule a free, no-obligation consultation with Dr. Wilson today to discuss your eligibility to seek compensation for TB exposure linked to contaminated bone repair putty.
The Centers for Disease Control said patients who underwent spinal fusions or fracture repairs and received the FiberCel putty from Donor Lot Number NMDS210011 are likely to have been exposed to the bacterium that causes Tuberculosis. TB is a communicable disease and can damage the lungs and other parts of the body. It can cause death if not treated.
The CDC is recommending that patients who received FiberCel putty from the recalled lot should undergo treatment for Tuberculosis, even if they are not displaying symptoms.
The recalled lot of FiberCel consisted of 154 units, all derived from the tissue of a single individual, Aziyo Biologics, Inc. said. The units were shipped to 37 medical facilities in 20 states in March and April.
Aziyo Biologics, Inc. said it instructed hospitals that received FiberCel from the recalled lot to quarantine and return any product. As of June 10, all unused units of this product lot have been sequestered.
Aziyo Biologics said it was investigating the source of the infection along with its distributor Medtronic, Inc., the CDC, and the Food and Drug Administration and had suspended all sales of FiberCel as a precaution.
The Law Offices of Dr. Michael M. Wilson MD, JD & Associates is reviewing potential FiberCel contaminated bone putty claims with the intent to pursue substantial payments for individuals and families who have been harmed. Patients who have been injured by this defective product may seek significant compensation.
Dr. Michael M. Wilson is an attorney and a physician who earned his undergraduate degree from the Massachusetts Institute of Technology and his legal and medical degrees from Georgetown University. He has focused in the area of medical malpractice for more than three decades and secured more than $100 million in settlements and verdicts on behalf of clients throughout the country. He is admitted to practice in the District of Columbia and New York as well as the U.S. Court of Appeals for the District of Columbia and the U.S. Supreme Court. He is listed in America’s Top 100 High Stakes Litigators.