Table 1.

Adverse events by category.

Category	n (%)	Intra-Op (%)	Post-Op (%)
Total Adverse Events	110	53 (48.2)	57 (51.8)
Total Device Issues	63 (57.3)	33 (52.4)	30 (47.6)
Break	33 (52.4)	27 (81.8)	6 (18.2)
Nonspecific break	23 (69.7)	19 (82.6)	4 (17.4)
Shoe Broke Off	4 (12.1)	4 (100)	0 (0)
Wire Broke from Piston	1 (3)	1 (100)	0 (0)
Shaft Broke from Wire	1 (3)	0 (0)	1 (100)
Shaft Broke Off	2 (6.1)	2 (100)	0 (0)
Phalange Broke Off	1 (3)	1 (100)	0 (0)
Disintegrated	1 (3)	0 (0)	1 (100)
Displacement	17 (27)	0 (0)	17 (100)
Nonspecific Displacement	6 (35.3)	0 (0)	6 (100)
Extrusion	11 (64.7)	0 (0)	11 (100)
Incorrect Size or Shape	7 (11.1)	3 (42.9)	4 (57.1)
Failure to Crimp	4 (6.3)	3 (75)	1 (25)
Loop of Stapes Open	2 (3.2)	0 (0)	2 (100)
Total Patient Issues	39 (35.5)	12 (30.8)	27 (69.2)
Hearing Loss	12 (30.8)	1 (8.3)	11 (91.7)
Distorted Hearing	2 (5.1)	0 (0)	2 (100)
Perforation	3 (7.7)	0 (0)	3 (100)
Erosion	6 (15.4)	0 (0)	6 (100)
Foreign Body in Patient	4 (10.3)	4 (100)	0 (0)
Nerve damage	1 (2.6)	1 (100)	0 (0)
Burns	1 (2.6)	1 (100)	0 (0)
Fracture	1 (2.6)	0 (0)	1 (100)
Pain	2 (5.1)	1 (50)	1 (50)
Inner Ear Injury	1 (2.6)	0 (0)	1 (100)
Vertigo	1 (2.6)	1 (100)	0 (0)
Dizziness	1 (2.6)	1 (100)	0 (0)
Headache and Pain During MRI	1 (2.6)	0 (0)	1 (100)
Drainage	1 (2.6)	0 (0)	1 (100)
Nausea	1 (2.6)	1 (100)	0 (0)
Nystagmus	1 (2.6)	1 (100)	0 (0)
Total Package Issues	8 (7.3)	8 (100)	0 (0)
Device Broken in Package	2 (25)	2 (100)	0 (0)
Contaminate Within Package	2 (25)	2 (100)	0 (0)
Unsealed Package	1 (12.5)	1 (100)	0 (0)
Improper Size Labeling	1 (12.5)	1 (100)	0 (0)
Incorrect Item Within Package	1 (12.5)	1 (100)	0 (0)
Missing Component	1 (12.5)	1 (100)	0 (0)