Mary Wilson
Well-known member
July 28, 2023: Updated information on number of patient exposures and affected states.
Background
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
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 of36 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.
Recommendations Issued to Date Include:
Background
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
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 of36 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.
Recommendations Issued to Date Include:
- 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. ...