A woman is suing Elutia, formerly Aziyo Biologics, after contracting tuberculosis from a product used in an April 2021 spine surgery, The Atlanta Journal-Constitution reported Oct. 17.
Five notes:
1. Tina and Steven Langford filed their lawsuit Aug. 29 and are seeking unspecified damages from Elutia. They are also suing two donor suppliers.
2. The lawsuit alleges that the FiberCel Fiber Viable Bone Matrix had human tissue from an infected donor. Ms. Langford had her surgery at Floyd Medical Center in Rome, Ga., and has since suffered side effects from the tuberculosis infection and treatments.
3. A spokesperson for Elutia told The Atlanta Journal-Constitution that it doesn't comment on pending litigation. The publication didn't get a response from DCI Donor Services, which was named in the lawsuit.
4. Elutia has faced multiple lawsuits related to FiberCel. In August, a couple from North Carolina also filed a lawsuit related to the infected bone grafts.
5. On June 2, 2021, the FDA issued an urgent voluntary recall of FiberCel. Aziyo initiated the voluntary recall in response to reports of patients testing positive for tuberculosis and postsurgical infections following the surgical implantation of FiberCel as part of an orthopedic or spinal procedure.