Table 2.

ETB (PORP) adverse events by category.

Category	n (%)	Intra-Op (%)	Post-Op (%)
Total Adverse Events	42 (100)	26 (61.9)	16 (38.1)
Total Device Issues	21 (50)	13 (61.9)	8 (38.1)
Break	10 (47.6)	8 (80)	2 (20)
Nonspecific break	8 (80)	7 (87.5)	1 (12.5)
Shaft Broke from Wire	1 (10)	0 (0)	1 (100)
Phalange Broke Off	1 (10)	1 (100)	0 (0)
Displacement	3 (14.3)	0 (0)	3 (100)
Nonspecific Displacement	3 (100)	0 (0)	3 (100)
Incorrect Size or Shape	2 (9.5)	2 (100)	0 (0)
Failure to Crimp	4 (19)	3 (75)	1 (25)
Loop of Stapes Open	2 (9.5)	0 (0)	2 (100)
Total Patient Issues	15 (35.7)	7 (46.7)	8 (53.3)
Hearing Loss	4 (26.7)	1 (25)	3 (75)
Distorted Hearing	1 (6.7)	0 (0)	1 (100)
Erosion	1 (6.7)	0 (0)	1 (100)
Foreign Body in Patient	2 (13.3)	2 (100)	0 (0)
Nerve damage	1 (6.7)	1 (100)	0 (0)
Burns	1 (6.7)	1 (100)	0 (0)
Pain	1 (6.7)	0 (0)	1 (100)
Inner Ear Injury	1 (6.7)	0 (0)	1 (100)
Dizziness	1 (6.7)	1 (100)	0 (0)
Headache and Pain During MRI	1 (6.7)	0 (0)	1 (100)
Nausea	1 (6.7)	1 (100)	0 (0)
Total Package Issues	6 (14.3)	6 (100)	0 (0)
Device Broken in Package	1 (16.7)	1 (100)	0 (0)
Contaminate Within Package	2 (33.3)	2 (100)	0 (0)
Unsealed Package	1 (16.7)	1 (100)	0 (0)
Incorrect Item Within Package	1 (16.7)	1 (100)	0 (0)
Missing Component	1 (16.7)	1 (100)	0 (0)