Medtronic Infuse Bone Graft

Medtronic Infuse Bone Graft is associated with complications considered to be life threatening for implant patients who received the Medtronic Infuse Bone Graft off label implanted in their neck area.

Medtronic Infuse bone grafts are man-made liquid bone stimulators.  The Medtronics Infuse bone graft is utilized to promote bone growth as well as replace spinal disks which are damaged. This medical device utilizes a man-made bone graft filled with liquid consistent with rhBMP-2 (recombinant human Bone Morphogenetici Protein). The use of rhBMP-2 eliminates the need for additional incisions normally done to harvest donor bone from a patient which is then used as an implant.  The intention is that overall pain in patients would be reduced by eliminating this additional step when implanted with the Medtronic Infuse Bone Graft.

In 2002, approval from the FDA came for the Infuse bone stimulator to be used only for the low back area, also known as the lumbar spinal area. Unfortunately, the Medtronic Infuse bone graft stimulator has been widely used in the neck or cervical area “off-label”, thus creating life-threatening complications.

The U.S. Department of Justice has begun investigating Medtronic for criminal promotion and marketing of the Medtronic Infuse bone graft stimulator.  The Medtronic Infuse bone graft stimulator has never been determined to be a safe or effective product for use in the cervical spine.

Known Medtronic Infuse Bone Graft Complications

When implanted in the cervical area, The Medtronic Infuse bone growth stimulator has known complications attributed with its use such as:

  • Problems with Swallowing, Breathing or Speaking
  • Airway Compression
  • Depression of the Respiratory System
  • Damage to the Nerves
  • Death

Additional complications which have been reported include feeding tube insertion, aid to assist the respiratory system, tracheotomies, anti-inflammatories as well as more surgery.  The FDA has put out a Public Health Notification  detailing numerous additional problems when the Medtronic Infuse Bone Stimulator has been used in the cervical area.

FDA Warning on Medtronic Off-Label Use

Many current Medtronic Infuse Bone Graft lawsuits allege the manufacturer illegally promoted the Medtronic bone graft for off-label uses.

Current Product Liability Claims

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Product liability litigation has been featured on:

Bernheim & Dolinsky: American Association of Justice.
Bernheim & Dolinsky: Miami-Dade Justice Association. Bernheim & Dolinsky: Broward County Bar Association. Bernheim & Dolinsky: Broward County Justice Association.
Bernheim & Dolinsky: Million Dollar Associates Forum.