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  • Report:  #1017347

Complaint Review: Medtronic

Medtronic Doctor published "overstated" benefits of INFUSE bone grafts off-label use, paid almost $800,000 Tempe, Arizona

  • Reported By:
    anonymous — California United States of America
  • Submitted:
    Wed, February 20, 2013
  • Updated:
    Wed, February 20, 2013
  • Medtronic
    2343 W Medtronic Way
    Tempe, Arizona
    United States of America
  • Phone:
  • Category:

According to THIS New York Times article medtronic paid Dr. Kuklo- a military doctor almost 800,000 dollars over a course of a few years. Favorable reports of the off-label use of the Medtronic INFUSE Bone Graft were pulled from medical journals after it was revealed that, "Dr. Kuklo had forged the names of four other doctors on the study and had cited data that did not match military records." Other doctors called the benefits "overstated"

The protein is SAFE to use in lower back spinal surgeries, but when used in the upper back/neck area reported side effects from the Medtronic bone graft include:


  • Uncontrollable bone growth, also known as ectopic bone growth 

  • inflammatory cysts

  • Paralysis

  • Labored Breathing

  • Nerve Damage

  • Difficulty eating or Speaking

  • Possible death
According to this website the FDA warned doctors in 2008 about the dangers of using Medtronic's INFUSE in the spine, but allegedly more than 70% of the complications reported from the INFUSE bone graft are a result of off label use.

Even worse Medtronic's earnings have consistently gone up over the past year- stocks are projected to value at 47% within this year (More than 14% growth!) while countless people could be injured from the off-label use of their products. 


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