Thanks yodon! I'm not sure if I'm understanding correctly. This path on the flowchart refers only to events taking place outside of the US. The wording comes directly from the draft MDR guidance (July 2013) - and yes, I know it's just a draft, but we feel it reflects current FDA thinking. I don't see ex-US events mentioned specifically in 21 CFR 803, but I could be missing it (does anyone know if it's there?).
The wording in the guidance is "FDA considers an event that occurs in a foreign country reportable under the MDR regulation if it involves a device that has been cleared or approved in the US - or a device similar to a device marketed by the manufacturer that has been cleared or approved in the US - and is also lawfully marketed in a foreign country". I don't think there's a requirement to consider whether the event could occur with ANY device you market in the US, just one that's essentially the same as the one with which the event occurred. The intention of the wording in the guidance (as I understand it) is just to cover the fact that there are often slight differences in device models between countries, and this doesn't exclude you from needing to report.