Adverse events related to device, procedure, other treatment for SI joint pain or pre-existing condition.
| NSM (n=46) | SI Joint Fusion (n=102) | |
|---|---|---|
| Category | N (%*) | N (%) |
| Related to iFuse implant Definitely related Probably related Total |
- - - |
2 (2.0%) 1 (1.0%) 3 (2.9%) |
| Related to NSM or iFuse procedure** Definitely related Probably related Total |
3 (6.5%) 1 (2.2%) 4 (8.7%) |
7 (6.9%) 10 (9.8%) 17 (16.7%) |
| Related to other treatment for SIJ pain Definitely related Probably related Total |
0 (0%) 0 (0%) 0 (0%) |
0 (0%) 1 (1.0%) 1 (1.0%) |
| Related to pre-existing condition Definitely related Probably related Total |
11 (23.9%) 6 (13.0%) 17 (37.0%) |
23 (22.5%) 17 (16.7%) 40 (39.2%) |
↵* Percent reported as number of events divided by number assigned to treatment.