The wife of an Indiana man is the most recent to sue after her husband reportedly died from tuberculosis following his spinal fusion surgery.
Wrongful Death Suit Hits Aziyo Over TB-Tainted Implant
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#medtronicSecondary#sofamordanek#aziyobiologics
Georgia Flinn (Flinn), as personal representative of the unsupervised estate of Gregory Flinn (Gregory), filed her wrongful death lawsuit in the Marion Superior Court in Indianapolis, Indiana. The lawsuit listed the following companies as defendants: Silver Spring, Maryland-based Aziyo Biologics, Inc.; Memphis, Tennessee-based Medtronic, Sofamor Danek USA, Inc.; Memphis, Tennessee-based SpinalGraft Technologies, LLC; and Indianapolis, Indiana-based Rapp Medical Systems, LLC. Flinn is seeking a trial by jury as well as damages.
This lawsuit is just one of many since Aziyo Biologics announced a voluntary recall of 154 units of the company’s FiberCel Fiber Viable Bone Matrix (FiberCel). The company issued the voluntary recall after hospitals began seeing post-surgical infection in some patients treated with FiberCel—including some positive tuberculosis cases. For OTW’s coverage of the recall, see “Bone Graft Product Recalled Over TB Contamination Fears.”
Flinn alleges that in April 2021 Gregory underwent a spine fusion and received a FiberCel implant. According to the complaint, three or four days after surgery Gregory “began to experience low-grade then high fevers, weakness, fatigue, back pain, night sweats, chills and rigors, confusion and a decreased appetite.”
In May 2021, Gregory purportedly sought treatment for “fever and weakness.” Two days later he was reportedly admitted to the hospital for observation where Flinn claims Gregory’s “fever spiked, he developed mental status changes and hypoxia and he was ultimately moved to the ICU [intensive care unit].”
Flinn’s complaint argues that Gregory suffered from a Mycobacterial tuberculosis infection which ultimately caused his death on May 23, 2021. In support of this claim, Flinn asserts that a Centers for Disease Control and Prevention post-mortem core biopsy of Gregory’s liver confirmed “immunohistochemical and molecular evidence of Mycobacterium tuberculosis.” Mycobacterium tuberculosis causes tuberculosis.
As of the date of this article the defendants have not yet filed a response.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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