Table 3.
Category |
n (%) |
Intra-Op (%) |
Post-Op (%) |
---|---|---|---|
Total Adverse Events | 68 | 26 (38.2) | 42 (61.8) |
Total Device Issues | 42 (61.8) | 20 (47.6) | 22 (52.4) |
Break | 23 (54.8) | 19 (82.6) | 4 (17.4) |
Nonspecific break | 15 (65.2) | 12 (80) | 3 (20) |
Shoe Broke Off | 1 (4.3) | 1 (100) | 0 (0) |
Wire Broke from Piston | 1 (4.3) | 1 (100) | 0 (0) |
Shaft Broke Off | 5 (21.7) | 5 (100) | 0 (0) |
Disintegrated | 1 (4.3) | 0 (0) | 1 (100) |
Displacement | 14 (33.3) | 0 (0) | 14 (100) |
Nonspecific Displacement | 3 (21.4) | 0 (0) | 3 (100) |
Extrusion | 11 (78.6) | 0 (0) | 11 (100) |
Incorrect Size or Shape | 5 (11.9) | 1 (20) | 4 (80) |
Total Patient Issues | 24 (35.3) | 4 (16.7) | 20 (83.3) |
Hearing Loss | 8 (33.3) | 0 (0) | 8 (100) |
Distorted Hearing | 1 (4.2) | 0 (0) | 1 (100) |
Perforation | 3 (12.5) | 0 (0) | 3 (100) |
Erosion | 5 (20.8) | 0 (0) | 5 (100) |
Foreign Body in Patient | 2 (8.3) | 2 (100) | 0 (0) |
Fracture | 1 (4.2) | 0 (0) | 1 (100) |
Pain | 1 (4.2) | 0 (0) | 1 (100) |
Vertigo | 1 (4.2) | 1 (100) | 0 (0) |
Drainage | 1 (4.2) | 0 (0) | 1 (100) |
Nystagmus | 1 (4.2) | 1 (100) | 0 (0) |
Total Package Issues | 2 (2.9) | 2 (100) | 0 (0) |
Device Broken in Package | 1 (50) | 1 (100) | 0 (0) |
Improper Size Labeling | 1 (50) | 1 (100) | 0 (0) |