Table 4

Device- or procedure-related events.

Event categoryn(%)b
Related to devicea
 Neuropathic pain related to device malposition
 SI joint or buttock pain
 SI joint pain after fall associated with inadequate
 device placement
 Hip pain related to periosteal bone growth around implant
7
3 (1.8%)
2 (1.2%)
1 (0.6%)
1 (0.6%)
Related to procedurea26
 Buttock pain
 Foot weakness related to anesthesia
 iFuse impingement
 Nausea/vomiting
 SI joint pain
 SI joint pain (inadequate stabilization)
 Urinary retention
 Vascular injury
 Wound drainage/irritation/infection
 Wound numbness		2 (1.2%)
1 (0.6%)
3 (1.7%)
3 (1.7%)
5 (2.9%)
3 (1.7%)
1 (0.6%)
1 (0.6%)
6 (3.5%)
1 (0.6%)

  • ↵a Number (rate) of events divided by number undergoing surgical procedure. Some events were related to both device and procedure.

  • ↵b Events rated as probably or definitely related to the device/procedure by the study site investigator.