Table 4:

Device/procedure/anesthesia–related adverse events during 2 years

No. of Patients^{^a}		Kyphoplasty (n = 191)	Vertebroplasty (n = 190)
With procedure/device/anesthesia-related (or possibly) AEs		12	11
Blood and lymphatic disorders	Bone marrow edema	0	1^{^b}
Gastrointestinal disorders	Constipation	1^{^c}	0
Immune system disorders	Hypersensitivity	0	1^{^c}
Injury or procedural complications	Cement embolism	1^{^d}	1^{^d}
	Implant site extravasation	0	1^{^e}
	Mental status changes postoperative	0	1^{^c}
	Procedural hypotension	1^{^c}	0
	Procedural nausea/vomiting	1^{^c}	0
	Procedural pain	3^{^f}	3^{^f}
	Spinal fracture	1^{^g}	0
Musculoskeletal disorders	Arthralgia	1^{^g}	0
	Back pain	2^{^g}	3^{^g}
	Muscle spasm	1^{^g}	0
	Symptomatic vertebral fracture	1^{^g}	2^{^g}
Psychiatric disorders	Hallucination	1^{^c}	0
Respiratory disorders	COPD	1^{^c}	0
	Hypoxia	0	1^{^c}
	Respiratory failure	0	1^{^c}
Vascular disorders	Hematoma	0	1^{^h}

Note:—COPD indicates chronic obstructive pulmonary disease.
↵a Patients may have had multiple AEs; all system organ class categories are listed when there was an event considered related (or possibly related) to device/procedure/anesthesia.
↵b In 1 patient, 1 event was considered nonserious and possibly related to bone cement.
↵c In 1 patient, 1 event was considered serious and related (or possibly related) to anesthesia and was resolved with medical intervention.
↵d In 1 patient, 1 event each was considered serious and bone cement–related (or possibly related). In each case, the event occurred after the surgical treatment of a subsequent fracture; the BKP event was resolved with oxygen, and the VP event was ongoing at final follow-up.
↵e In 1 patient, 1 event was considered bone cement–related and nonserious. A spinal canal leak was detected intraoperatively; CT was immediately performed without significant canal stenosis observed with no medical intervention given.
↵f Three patients in each group with 3 (2 serious) and 4 (all serious) events in the BKP and VP groups, respectively, were considered device-related (or possibly related) but were resolved.
↵g The number of patients reflected in the Table had events that were considered serious and related (or possibly related) to the device.
↵h In 1 patient, 1 event was nonserious and possibly related to the procedure (likely a prone position on the operating table).