“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
The O-ARM® system is a multidimensional surgical imaging platform optimized for use in spine surgeries and surgeries related to orthopedic trauma. It brings intraoperative image projection to a new level with superior quality of the image and visual field in 2 and 3 dimensions, allowing the surgeon to confirm the accuracy of advanced surgical procedures before the patient leaves the operating room. Integrating seamlessly with navigation, the O-ARM ® SYSTEM reduces x-ray exposure, increasing safety for both medical personnel and patients.
The O-ARM system is a multidimensional surgical imaging platform optimized for use in dorsal spinal surgeries and surgeries related to orthopedic trauma. Projection of intraoperative image to a new level with superior quality of the image and visual field in 2 and 3 dimensions, allowing the surgeon to confirm the accuracy of advanced surgical procedures before the patient leaves the operating room. Integrating no problems with navigation, the O-ARM SYSTEM reduces exposure to lightning rods, increasing safety for both medical personnel and patients.