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# Dingell Concerned About TB from Bone Grafts
- URL: https://www.fdaweb.com/dingell-concerned-about-tb-from-bone-grafts/
- Published: 2023-08-23T12:00:00.000Z
- Updated: 2026-09-14T18:52:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155165

Rep. **Debbie Dingell** (D-MI) has written to FDA commissioner **Robert Califf** and CDC director **Mandy Cohen** expressing concern about an outbreak of tuberculosis (TB) linked to the implantation of contaminated bone graft material supplied by Aziyo Biologics in Silver Spring, MD. In an 8/17 [letter](https://debbiedingell.house.gov/news/documentsingle.aspx?DocumentID=4492&ref=fdaweb.com), Dingell said a Michigan resident received Aziyo’s ViBone Moldable in a surgical procedure, was treated in an intensive care unit for a severe post-surgical TB infection, and ultimately died.

She said the CDC has indicated it is working to respond to reported TB cases that appear to be linked to the bone graft material and that it has been reported that 36 patients underwent surgical or dental procedures using products from the contaminated lot.

Dingell asked Califf and Cohen to respond to these questions:

- how FDA and CDC are monitoring and addressing the current TB outbreak linked to tainted bone tissue materials and how they are working with Aziyo Biologics on the ongoing investigation;
- whether the agencies have identified the total number of patients who received products from the contaminated lot and how many have developed TB infections;
- whether all patients have been notified, evaluated, and treated;
- whether all unused products from the recalled lot have been sequestered and safely disposed of;
- how FDA determines tissue donor eligibility and whether TB-related risk factors are considered in the assessment;
- what FDA’s current testing requirements are for human tissue products and what infections are tested for;
- what FDA has done since a 2021 TB outbreak to prevent the implantation of contaminated bone tissue;
- whether FDA has plans to update its bone tissue testing requirements to mandate testing for TB in tissue products;
- whether FDA needs new authorities or resources to prevent similar outbreaks in the future; and
- whether the CDC can confirm that genetic sequencing from the patients who received Aziyo Biologics’ bone grafts indicates the bacteria came from the same donor source.