Table 1.

Postmarket complaints with the minimally invasive iFuse SI Joint Fusion System® (SI-BONE, Inc., San Jose, CA, USA)

Complaints	All patients (n = 5319)
		Patients with complaints (n, %)	204 (3.8)
Clinical events, (n, %)
Any pain	119 (2.2)
Nerve impingement	48
Recurrent sacroiliac joint	43
Unknown cause	18
Neuropathic pain	13
Inadequate pain relief	12
Malalignment	11
Piriformis syndrome	7
Local soft tissue pain	5
Hematoma/excessive bleeding	11 (0.2)
Iliac fracture	4 (<0.1)
Superficial wound infection	3 (<0.1)
Deep venous thrombosis	2 (<0.1)
Deep wound infection	1 (<0.1)
Pulmonary embolism	0
Vascular injury	0
Gastrointestinal injury	0
Genitourinary injury	0
Sacral fracture	0
Death	0
Device-related events, (n, %)
Pin bind/bend/break	43 (0.8)
Pin advancement	14 (0.3)
Radiographic halo	13 (0.2)
Migration	4 (<0.1)
Procedure-related events, (n, %)
Any improper device placement	72 (1.4)
Medial	20
Anterior	18
Dorsal	14
Cephalad	12
Proud	8
Inferior	2
Other malposition	2
Any improper device size	36 (0.7)
Too short	30
Too long	7

Note: Sum of subgroups may be greater than the total due to multiple events in the same patient.