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What Is The Aziyo FiberCel Case All About? – Personal Injury



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On June 16, 2021, Morris James LLP filed a lawsuit against Aziyo Biologics, Inc. (Aziyo)
and Medtronic entities (Medtronic) on behalf of Delawarean, Richard
Williams after he became infected with tuberculosis after spine
surgery. This is the first lawsuit filed in relation to the
contamination of FiberCel Viable Bone Matrix (FiberCel) with
tuberculosis (TB.)

FiberCel is a fiber-based bone repair product
manufactured by Aziyo and distributed in the U.S. by Medtronic. It
is made from human tissue and engineered to maintain
characteristics of natural tissue. FiberCel is used in orthopedic
or reconstructive bone grafting procedures in combination with
autologous or allograft bone, or alone as a bone graft. (Autologous
bone is the patient’s own bone whereas allograft bone comes
from a donor.)

Tuberculosis is a serious, communicable disease
caused by a bacterium called mycobacterium tuberculosis. It can be
life-changing and life-threatening, particularly in vulnerable
patients such as those recovering from surgery. TB is also highly
communicable therefore all TB infections must be reported to the
local or state health department tuberculosis program.

The potential contamination of Aziyo’s FiberCel
product was only made public in June 2021.
On June 2,
Aziyo issued an urgent voluntary notification
recalling one lot (Donor Lot No. NMDS210011) of Fibercel in
response to a customer complaint. A hospital had reported
post-surgical infection in 7 of 23 patients that received FiberCel
from this lot, four of whom tested positive for TB. According to
Aziyo, the contaminated material came from one single donor, and
was distributed in 154 units to 20 states across the country. The
recall instructed all hospitals that had received Fibercel from
this lot to immediately quarantine and return any unused product.
According to a June 7, 2021 press release,
Aziyo has now suspended all distribution of FiberCel, and, together
with the U.S. Centers for Disease Control and
Prevention
(CDC,) is investigating the source of the
contamination.

Richard Williams was implanted with FiberCel from the
contaminated lot during spinal fusion surgery in April
2021.
Mr. Williams, the plaintiff in this first lawsuit,
was a patient at Christiana Care in Delaware who developed a
post-operative infection and tested positive for TB. As a result of
this, he had to have revision surgery on June 7, 2021 to remove the
contaminated FiberCel and redo his spinal fusion, and now requires
ongoing medical care and monitoring for TB. The success of his
underlying cervical spinal procedure was also affected because the
revision surgery required his spine to be fused at a higher level
resulting in decreased range of motion and more substantial
permanent injury.

The extent of the FiberCel contamination and its impact
is not yet known.
Mr. Williams is just one patient. Even
at this early stage, Aziyo has admitted that the known contaminated
FiberCel lot was distributed in 154 units to 20 states. It is fully
expected that there are more injured victims out there, and that
more lawsuits will follow. Aziyo also appears to be braced for
future litigation, having suspended its recent revenue guidance for
2021 due to “the uncertainty regarding any potential impact to
Aziyo’s business resulting from the recall and the pause in
FiberCel sales.”

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.

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