Category: Alerts
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. CDC is working closely with health departments, hospitals, and surgical centers in the affected states, and the U.S. Food & Drug Administration to prevent further patient harm and to prevent similar outbreaks in the future. The product manufacturer sent a voluntary recall notice for this bone repair product, FiberCel, on June 2, 2021, and has worked closely with public health authorities. As of June 10, all unused units of this product lot have been sequestered.
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.
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