FiberCel Fiber Viable Bone Matrix

Tuberculosis Warning After Surgery!

On June 2, 2021, Aziyo Biologics Inc. issued a voluntary recall of an entire lot of its FiberCel Fiber Viable Bone Matrix after learning of the development of post-surgery tuberculosis in at least 72 patients. Subsequent testing performed by the Centers for Disease Control and Prevention (“CDC”) has confirmed the presence of mycobacterium tuberculosis, the bacteria causing tuberculosis, in the recalled product lot. This lot was contaminated.

If you or a loved one has developed tuberculosis after orthopedic or spinal surgery, contact one of our defective medical device lawyers at GoldenbergLaw for a free consultation. GoldenbergLaw has 35 years of experience handling national contamination cases.

How Do I Know This Happened to Me?

You may have received a letter from your doctor or hospital notifying you of this problem. Or you may have been exposed to someone that contracted tuberculosis. If you suspect this involves you, you should contact your doctor immediately.

Case Quick Facts

The Problem

Aziyo Biologics Inc. developed the FiberCel Fiber Viable Bone Matrix (“VBM”) to be used in spinal and orthopedic surgeries for bone regeneration and reconstruction. The VBM is made of human tissue from a donor that is turned into putty and applied to the bone during surgery. The human tissue used in the recalled VBM lot, Lot #NMDS210011, came from a single donor. The recalled lot contained 154 units of product and was shipped to twenty different states between March 3, 2021 and April 2, 2021. Of the 154 lots that were shipped to hospitals around the country, 136 were implanted into 113 patients.

Since the now-recalled lot has been implanted in the 113 patients, there have been reported cases of tuberculosis in at least 72 patients. Among those 72 cases, eight patients who received the product from the recalled lot have died – although the cause of death is still being determined. Several patients have required subsequent revision surgery to have the recalled VBM product extracted from their body. Following the outbreak of tuberculosis in these patients, the CDC performed PCR testing which confirmed the presence of mycobacterium tuberculosis in the recalled VBM lot. All patients who received a VBM from the recalled lot are receiving treatment for tuberculosis.

The Injuries

Patient exposure to mycobacterium tuberculosis can lead to the development of tuberculosis. Tuberculosis is a communicable disease that can have severe complications like joint damage, meningitis, liver or kidney problems, heart disorders, and even death. The path to recovery for those exposed to tuberculosis can be painful and arduous, and it usually requires six to nine months of antibiotic treatment.

Symptoms of Tuberculosis Include:

  • Fatigue
  • Fever
  • Coughing
  • Coughing up blood or mucus
  • Chest pain
  • Chills
  • Unintentional weight loss
  • Night Sweats

GoldenbergLaw Can Help

If you or a loved one have developed tuberculosis after an orthopedic or spinal surgery, please contact GoldenbergLaw. We will deliver the “Gold Standard” advocacy you deserve.

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