Ready to upload
Adverse Occurrence type:
Rare; M. tuberculosis transmission via bone graft was last described in 1953.
Time to detection:
Nineteen (83%) of 23 surgical patients reported new TB-related symptoms beginning 2–66 days (median = 19 days) after product implantation. Fifteen (65%) of these patients reported constitutional signs and symptoms, including fever, chills, night sweats, weight loss, fatigue, and loss of appetite. Sixteen (70%) had redness, pain, or drainage at the surgical site; four (17%) experienced neurologic symptoms, including paresthesia and dysphagia. Seven (30%) experienced pulmonary symptoms, including cough and shortness of breath. Four (17%) patients were asymptomatic. Sixteen (70%) required hospital readmission 23–84 days after product implantation (median = 52 days). Twelve (52%) underwent additional surgical procedures to manage complications of infection. One patient died at home 3 weeks after product implantation, which was 2 months before the product recall.
Alerting signals, symptoms, evidence of occurrence:
New TB-related constitutional signs and symptoms in spine surgery patients who all received the same bone graft type and lot number. Signs and symptoms included fever, chills, night sweats, weight loss, fatigue, loss of appetite, cough, and shortness of breath. Many had redness, pain, or drainage at the surgical site, and some experienced neurologic symptoms, including paresthesia and dysphagia. The investigation found high attack rates of spinal and disseminated tuberculosis after surgical implantation of the bone product and multiple opportunities for M. tuberculosis exposure related to surgery and patient care. In addition to risk to recipients, health care personnel could have been exposed to M. tuberculosis during implantation of this bone product and subsequent procedures involving suctioning, drilling, wound irrigation, and decontamination of cannulated instruments. In addition, health care personnel and patients could have been exposed to M. tuberculosis from patients who had received this bone product and subsequently developed draining tuberculous lesions or pulmonary tuberculosis. The hospital identified 152 health care personnel and seven patients who were exposed to recipients of this bone product lot number who had tuberculous abscesses or pulmonary tuberculosis.
Demonstration of imputability or root cause:
Among 19 patients who had received microbiologic testing of a vertebral, paraspinal soft tissue, or sputum specimen, 15 (79%) had a positive acid-fast bacilli smear, M. tuberculosis nucleic acid amplification test, or culture. Among 21 patients who had received spinal imaging, 19 (90%) had findings consistent with infection, including abscesses (17, 81%) and osteomyelitis or discitis (eight, 38%). Among 21 patients with sputum testing or chest imaging, six (28%) demonstrated evidence of pulmonary tuberculosis, suggesting bloodborne dissemination of M. tuberculosis. Isolates cultured from specimens from three patient specimens were susceptible to all first-line medications and shared a genotype not previously identified in the United States drug-susceptibility testing and genotyping of subsequent isolates were pending. The bone product was shipped frozen.
1. https://www.cdc.gov/mmwr/volumes/70/wr/mm7036a4.htm 2. Food and Drug Administration. Urgent voluntary notification: FiberCel Fiber Viable Bone Matrix (“FiberCel”)—lot number: NMDS210011. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2021. https://www.fda.gov/vaccinesblood-biologics/recalls-biologics/urgent-voluntary-notification-fibercelfiber- viable-bone-matrix-fibercel-lot-number-nmds210011. 3. James JI. Tuberculosis transmitted by banked bone. J Bone Joint Surg Br 1953;35-B:578 PMID:13108919https://doi.org/10.1302/0301-620X.35B4.578.
A new publication of this outbreak is pending and will be useful as a reference.
Expert comments for publication:
All 22 living patients began standard four-drug treatment for drug-susceptible tuberculosis 41–91 days after product implantation (median = 69 days). It's important to begin therapy, even if only prophylactically, as early as possible. It was reported that isolates cultured from patient specimens were susceptible to all first-line medications. The hospital’s rapid detection of this unusual cluster triggered a multistate investigation resulting in sequestration of all unused units of the contaminated product, identification of all patients who underwent surgical procedures with the contaminated bone product lot, and initiation of tuberculosis treatment by all living patients.