June 2021
Multistate Tuberculosis (TB) Outbreak Linked to Suspected Contaminated Bone Graft Material Used in Surgery
Background
On May 25, 2021, CDC received notification of a cluster of patients at a single facility who developed Mycobacterium tuberculosis (MTB) surgical site infection following spinal fusion surgery. As of June 10, 2021, post-operative patients from multiple facilities in multiple states have developed surgical site infections (abscess, phlegmon, osteomyelitis, and/or discitis) or other manifestations of MTB infection (e.g., miliary, disseminated, meningitis). MTB was isolated from the wounds of multiple patients during post-operative evaluations.
The surgical procedures all used a single product lot of FiberCel, a bone allograft, manufactured by Aziyo Biologics and distributed by Medtronic (FiberCel lot NMDS210011). On June 2, the manufacturer issued a voluntary nationwide recall of the single lot of FiberCel linked to these patients.
The manufacturer reported that 154 units of this product, from a single donor, were shipped to more than 30 facilities in 20 states (Arizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Minnesota, North Carolina, Ohio, Oregon, South Dakota, Texas, Virginia, Washington). CDC has worked with the affected state and local health departments to determine the disposition status of all distributed units of this lot and, where relevant, recipient patient clinical status.
Guidance
All facilities and states have been contacted and all unused products have been sequestered. There were no affected lots delivered to Wisconsin.
For patients who may have received allograft material out of state:
Given the risk of post-operative infection and abscess formation, vertebral (or other skeletal) osteomyelitis, and rapid progression of severe disseminated disease, CDC recommends that all patients who have received this product lot immediately begin and undergo full treatment for active TB disease. If you encounter a patient in Wisconsin who may have received this allograft material out of state, please contact the Wisconsin TB Program at 608-261-6319.
M. tuberculosis grown from specimens obtained from the initial patients within this cluster was found to be susceptible to all first-line medications (i.e., isoniazid, rifampin, pyrazinamide, ethambutol) and thus far appears to have a unique genotype not previously identified in the United States. More information on genotyping and whole genome sequencing will be shared as available.
Facilities should report adverse health consequences to FDA’s MedWatch Adverse Event Reporting Program:
Wisconsin Tuberculosis (TB) Program Contact Information
Main WTBP phone number: 608-261-6319
WTBP fax: 608-266-0049
WTBP group email: DHSWITBProgram@dhs.wisconsin.gov
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