Sacroiliac Joint Pain

General Discussions

3 Responses to “General Discussions”

1. 
   impatient

   Having read the [news regarding] the SI-Bone method … I wonder if any revisions had been necessary among the 2000 successful treatments and how that worked.
   February 15th, 2012 at 5:27 am
2. 
   

   admin

   According to the data found in the USFDA’s MAUDE (Manufacturer and User Facility Device Experience) only 8 reports of “adverse events” involving the product in the United States were reported. In all cases the manufacture’s narrative states that “Based upon the complaint information and investigation, there is no evidence to suggest that the device was out of specification.” For complete details please search the database here (n.b., you will need to extend the date range and search for “si-bone” and separately “sibone”).

   Please note that any surgical intervention involves risk and potential for complications.

   Additionally, MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices.
   February 21st, 2012 at 5:18 pm
3. 
   impatient

   Thanks for the information. In the USFDA’s MAUDE (Manufacturer and User Facility Device Experience) there are 41 reports of adverse events, most of which were related to injuries of nerves or vessels. I wonder how many non reported there are. Percutanous insertion seems to be quite risky.
   November 12th, 2012 at 2:24 pm