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Reported Events Associated With Spine Robots: An Analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience Database.

Gregory J KirchnerAndrew H KimAriel H KwartJohn B WeddleJesse E Bible
Published in: Global spine journal (2022)
As more robot-assisted spine systems gain FDA approval and the adoption of these systems continues to grow, documenting and understanding the range of reported events associated with each "tool" is imperative to balancing patient safety with surgical innovation. This study of the MAUDE database provides a unique summary of reported events associated with robot-assisted spine systems that is not directly linked to a research setting.
Keyphrases
  • robot assisted
  • patient safety
  • drug administration
  • minimally invasive
  • quality improvement
  • adverse drug
  • emergency department
  • climate change
  • human health