Bone Graft Putty Tuberculosis Recall Lawsuit
A contaminated bone repair product used in orthopedic and spinal surgeries may be responsible for a recent tuberculosis outbreak that left more than 100 people infected and at least eight dead, news reports say.
Aziyo Biologics makes FiberCel Fiber Viable Bone Matrix, a bone putty made from human cells used to speed and promote healing after a variety of orthopedic procedures. On June 2, 2021, the U.S. Food and Drug Administration (FDA) issued an urgent voluntary recall of 154 containers of the defective product after receiving reports of post-surgical infections in patients treated with putty from the same batch and same donor.
The product was shipped to 37 facilities in 20 states between March 3 and April 2. According to the Centers for Disease Control and Prevention (CDC), 136 units were implanted in 113 patients.
Why is the Aziyo Biologics Bone Matrix Putty Recalled?
Aziyo recalled the bone matrix after receiving reports of post-operative infections in seven of 23 patients who received FiberCel at an unidentified hospital. The product is contaminated with mycobacterium tuberculosis, the bacteria that causes tuberculosis (TB).
Tuberculosis is an infection that primarily affects the lungs, but can also impact the kidneys, spine, and brain. Individuals may have a latent infection, where no symptoms are present, or active TB, when the illness makes the person sick and contagious to others.
In a statement, the CDC says patients who received spinal fusions or fracture repairs using FiberCel from Lot #NMDS210011 are likely to have been exposed to the bacteria. Officials recommend that anyone treated with the Aziyo bone putty be treated for tuberculosis, even if they do not appear sick.
Reported Deaths and Infection
Currently, 105 people are undergoing treatment for tuberculosis after receiving the recalled product. The agency is still investigating the cause of death for the eight patients who died after their surgeries.
Learn Your Legal Options if You Were Treated with FiberCel Viable Bone Matrix
Patients should be able to rely on medical supply manufacturers to make products that are safe and subject to the most rigorous safety testing. If you or a loved one was exposed to tuberculosis after being treated with FiberCel by Aziyo Biologics, you could have a valid defective product lawsuit against Aziyo or Medtronic, Inc., the product’s distributor.
Talk to an experienced attorney at Bertram Law Group today. With more than 30 years of experience, our lawyers take a unique approach to complex medical negligence cases in Washington, D.C., Maryland, and Virginia. As former defense attorneys for health care providers, our medical malpractice lawyers have an insider’s perspective on the medical industry and will use these invaluable insights to your benefit, crafting aggressive litigation strategies aimed at recovering maximum compensation.
Lawsuits are already being filed against Aziyo and Medtronic. Call or contact us today to learn whether you have a case.