On June 2, 2021, the FDA issued an “Urgent Voluntary Notification: FiberCel Fiber Viable Bone Matrix (“FiberCel”) – Lot Number: NMDS210011” stating: “Aziyo Biologics, Inc., (“Aziyo”) is the manufacturer of record for FiberCel Fiber Viable Bone Matrix (“FiberCel”) and is voluntarily recalling one Lot of the FiberCel product, Donor Lot Number: NMDS210011. This voluntary recall is being issued out of an abundance of caution following a customer complaint from one hospital that initially reported post-surgical infection in 7 of the 23 patients that have received FiberCel from this Donor Lot. Four of these patients have tested positive for Tuberculosis.”
The CDC subsequently issued a notification stating: “CDC is working to respond to a tuberculosis (TB) cluster in patients who had recently undergone spinal surgery that used a single lot of a bone repair product. TB is caused by a bacterium called Mycobacterium tuberculosis (MTB) and can cause severe disease and death if untreated … Patients who underwent spinal fusions or fracture repairs using FiberCel products from Lot #NMDS210011 are likely to have been exposed to MTB. Given the risk of localized TB disease in areas involved in surgery, TB disease in the spine or in other bones, and TB disease in other parts of the body, CDC has recommended that all patients who received this product lot receive treatment for TB disease. At present, there is no indication that other units of FiberCel are affected by this situation.”
What Is FiberCel?
According to Aziyo, FiberCel is “a fiber-based bone repair product made from human tissue and engineered to maintain characteristics of natural tissue. It is marketed for use in orthopedic or reconstructive bone grafting procedures in combination with autologous bone or other forms of allograft bone or alone as a bone graft. FiberCel provides handling properties that are critical for use as a bone void filler in various orthopedic and spinal procedures. FiberCel contains cancellous bone particles with preserved living cells and demineralized cortical bone fibers to facilitate bone repair and healing.”
Aziyo issued a statement regarding FiberCel and its alleged association with TB: “a voluntary recall pertaining to a single donor lot of its FiberCel Fiber Viable Bone Matrix, a bone repair product made from human tissue that is used in various orthopedic and spinal procedures … was issued to hospitals that received product from this specific lot following the Company’s learning of post-surgical infections in patients treated with FiberCel, including some patients that tested positive for tuberculosis. The lot consists of 154 units of FiberCel, all derived from a single donor, that were shipped to facilities in 20 states.”
If you or a loved one may have contracted TB after undergoing surgery during which FiberCel was used, you should promptly contact a local medical malpractice lawyer who may investigate your FiberCel and TB claim for you and represent you or your loved one in a FiberCel claim, if appropriate.
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