Multistate outbreak of tuberculosis (TB) associated with a suspected contaminated bone allograft material used in surgical procedures

Background

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 Administrationexternal icon, 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.

Recommendations Issued to Date Include:

• Surgeons should continue to work with their respective health department’s TB program to immediately contact patients who underwent surgery using FiberCel lot #NMDS210011 for evaluation and treatment. These patients should immediately begin drug treatment for TB disease, even if asymptomatic. Treatment should be coordinated with infectious disease and TB experts. Medical consultation can be requested through the TB Centers of Excellence for Training, Education, and Medical Consultation.
• Hospitals and surgical centers should work to identify any healthcare personnel who may have been exposed to MTB during surgical procedures or during patient care.
• Hospitals should report adverse patient outcomes to FDA’s MedWatch Adverse Event Reporting programexternal icon.

Additional Information for patients and their healthcare providers

• Notes from the Field: Tuberculosis Outbreak Linked to a Contaminated Bone Graft Product Used in Spinal Surgery — Delaware, March–June 2021 | MMWR (cdc.gov)
• For more information on TB visit: Tuberculosis (TB) | CDC
• For information on healthcare personnel isolation precautions for TB disease: CDC Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007) (see Appendix A)
• For more information on the product recall: Urgent Voluntary Notification: FiberCel Fiber Viable Bone Matrix (“FiberCel”) – Lot Number: NMDS210011 | FDAexternal icon