Tuberculosis (TB) Disease Associated with Suspected Contaminated Viable Bone Matrix Material Used in Surgical and Dental Procedures
- August 11, 2023: Updated At a Glance Case Counts.
CDC is working to respond to tuberculosis (TB) disease cases associated with viable bone matrix material. The cases appear to be linked to a single product lot used in surgical and dental procedures. Shipments of this product lot were sent to thirteen facilities in seven states (California, Louisiana, Michigan, New York, Oregon, Texas, and Virginia) between February 27, 2023, and June 20, 2023.
People who received product from implicated lot: 36
Facility Type: Hospitals and Dental Offices
The product manufacturer sent a voluntary recall notice for this product on July 13, 2023. All patients, facilities, and states involved have been contacted and all unused units of this product lot have been sequestered, meaning they have been removed from inventory and will not be used. A total of 36 people had surgery or dental procedures using product from this lot. CDC and FDA are working with state and local health departments, hospitals, surgical centers, and dental offices in the affected states to ensure patients are rapidly evaluated and treated, prevent further patient harm, and determine if additional measures can be taken to prevent similar outbreaks in the future.
TB is caused by a bacterium called Mycobacterium tuberculosis (MTB) and can cause severe disease and death if untreated.
- CDC recommends that all patients who received these products (#TDS222820) begin treatment for TB disease, even if they do not have any symptoms. Healthcare providers should continue to work with their respective health department’s TB program to ensure patients who underwent surgery using ViBone Moldable or alloOss Plus lot #TDS222820 receive evaluation and treatment. Treatment should be coordinated with infectious disease and TB experts. Healthcare providers can request medical consultation through the TB Centers of Excellence for Training, Education, and Medical Consultation.
- Hospitals and dental offices should work to identify any healthcare personnel who may have been exposed to Mycobacterium tuberculosis during patient surgery or during patient care.
- Healthcare providers should report adverse patient outcomes to FDA’s MedWatch Adverse Event Reporting program.
- Healthcare providers and facilities should also notify the manufacturer of adverse patient outcomes using the procedures detailed in the manufacturer’s communications.
- Important Information for Human Cell, Tissue and Cellular and Tissue-based Product (HCT/P) Establishments Regarding Tuberculosis Outbreaks Linked to a Bone Matrix Product | FDA
- 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: Aziyo Biologics Announces Voluntary Recall of Viable Bone Matrix Products | Aziyo Biologics, Inc.