The Medtronic InFUSE Bone Graft system received premarket approval from the FDA in 2002 and is designed to stimulate bone growth in targeted areas of the spine. Although only approved for a specific anterior approach surgical procedure, Medtronic encouraged the off-label use of the InFUSE bone graft system in cervical and posterior surgical procedures. The Medtronic InFUSE bone graft system has been implanted in more than 500,000 patients by over 2,300 surgeons. The off-label use of the Medtronic InFUSE bone graft system has led to side effects ranging from chronic pain, nerve injury, infertility, tumors, and life-threatening injuries. During this informative 90-minute teleseminar, gain an understanding of the Medtronic medical device, preemption,and much more.
Agenda Topics Include:
• What is InFUSE? Overview and History
• Safety Instructions, Warnings, and Problems
• Preemption and Promotion of Off-Label Use
• Related Injuries, Screening Cases, and SOL Issues
• Question and Answer Session
AGENDA
Moderator Instructions
Audra Davie, NM
What is InFUSE? Overview and History
Martin Crump, MS
Safety Instructions, Warnings, and Problems
Peter J. Brodhead, OH
Preemption and Promotion of Off-Label Use
Stuart Lee Goldenberg, MN
Related Injuries, Screening Cases, SOL Issues
Adam T. Funk, NM
Question and Answer Session
Adjourn
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