Federal health officials have launched an investigation into a rare tuberculosis outbreak, which may be linked to contaminated FiberCel Bone Matrix tissue products that were used during spine and orthopedic procedures.
The U.S. Centers for Disease Control and Prevention (CDC) announced that the agency is investigating a cluster of tuberculosis cases among patients who recently received certain lots of Aziyo Biologics FiberCel Bone Matrix tissue products, which may have been contaminated with a bacterium that causes the disease.
FiberCel is a fiber-based bone repair product, which is engineered to maintain characteristics of natural tissue for bone grafts or alone as a bone void filler, and contains preserved living cells from donors to facilitate bone repair and healing in recipients.
According to the investigation notice, the CDC is instructing more than 100 patients who recently received FiberCel Bone Matrix tissue products for spinal surgery or fracture repairs to be screened for Tuberculosis, indicating a certain lot of the product derived from a single donor may have been contaminated with Mycobacterium tuberculosis (MTB).
The investigation notice indicates at least 113 patients who received Aziyo Biologics FiberCel products with Lot #NMDS210011 have likely to have been exposed to MTB, and should seek treatment and testing immediately.
Of the patients who received FiberCel Bone Matrix tissue from the impacted lot, the CDC has become aware of seven post-surgical infections, four Tuberculosis diagnosis and at least eight patient deaths.
Tuberculosis is caused by the Mycobacterium tuberculosis bacteria, which spreads through the air when a person with TB in their lungs or throat coughs, sneezes, or talks. The infections are of such concern they need to be reported to the local or state health department tuberculosis program.
While most people infected with TB do not show symptoms, symptoms can include chest pain, breathing complications, chronic coughing, fatigue, chills, loss of appetite, shortness of breath and swollen lymph nodes. Treatment of the infection often involves an extended course of antibiotics.
The CDC investigation was announced following a FiberCel Fiber Viable Bone Matrix recall issued by the U.S. Food and Drug Administration (FDA) on June 2. The recall included FiberCel products with product numbers VBM9901, VBM9905, and VBM9910 from lot number NMDS210011 that were derived from a single donor, and suspected to be the source of several Tuberculosis transmissions in patients who recently underwent spinal surgeries.
Aziyo Biologics, Inc., the manufacturer, announced it would be suspending sales of FiberCel until further notice out of caution for its customers. Aziyo also issued an Urgent Notification Letter on June 2 to hospitals which received the product from the affected lot. The notification instructs customers who received FiberCel from this donor lot to examine its inventory and quarantine any remaining product.
The FDA is instructed hospitals and surgeons should identify their patients and notify them at once of the recall and quarantine any remaining product and return it to Aziyo. The manufacturer announced it will provide prepaid shipping containers for the return of any unused FiberCel.
Complaints associated with the FiberCel product recall should be directed to Medtronic by calling 888-869-2435.