All Treatment Emergent Adverse Events through 24 Months in US IDE Study – All Study Subjects.
| Mobi-C | ACDF | |||
|---|---|---|---|---|
| Complication | #Patients (% of 179) | Total Events | #Patients (% of 81) | Total Events |
| All Adverse Events 1 | 170 (95.0%) | 1229 | 75 (92.6%) | 688 |
| Anatomy/Technical Difficulty | 11 (6.1%) | 12 | 2 (2.5%) | 4 |
| Cervical –Study Surgery | 4 (2.2%) | 4 | 2 (2.5%) | 3 |
| Cervical – Non Study Surgery | 5 (2.8%) | 6 | 1 (1.2%) | 1 |
| Non-Cervical | 2 (1.1%) | 2 | 0 (0.0%) | 0 |
| Cancer | 4 (2.2%) | 5 | 1 (1.2%) | 2 |
| Cardiovascular | 20 (11.2%) | 26 | 10 (12.3%) | 10 |
| Death | 0 | 0 | 0 | 0 |
| Dysphagia/Dysphonia | 20 (11.2%) | 26 | 17 (21.0%) | 20 |
| Dysphagia | 19 (10.6%) | 22 | 15 (18.5%) | 17 |
| Dysphonia | 3 (1.7%) | 4 | 3 (3.7%) | 3 |
| Gastrointestinal | 39 (21.8%) | 60 | 15 (18.5%) | 37 |
| Heterotopic Ossification | 9 (5.0%) | 10 | 4 (4.9%) | 4 |
| Cervical - Index Level | 5 (2.8%) | 5 | 0 (0.0%) | 0 |
| Cervical - Adjacent Level | 1 (0.6%) | 1 | 1 (1.2%) | 1 |
| Non Cervical | 4 (2.2%) | 4 | 3 (3.7%) | 3 |
| Infection | 33 (18.4%) | 51 | 20 (24.7%) | 28 |
| Superficial Wound – Cervical | 6 (3.4%) | 7 | 1 (1.2%) | 1 |
| Deep Wound – Cervical | 0 | 0 | 0 | 0 |
| Other Wound - Non Study Surgery | 1 (0.6%) | 1 | 3 (3.7%) | 3 |
| Systemic | 8 (4.5%) | 9 | 2 (2.5%) | 3 |
| Local | 20 (11.2%) | 34 | 18 (22.2%) | 21 |
| Malpositioned Implant | 2 (1.1%) | 2 | 1 (1.2%) | 1 |
| Neck and/or Arm Pain | 102 (57.0%) | 212 | 47 (58.0%) | 98 |
| Neck Pain | 74 (41.3%) | 123 | 37 (45.7%) | 56 |
| Arm Pain | 46 (25.7%) | 76 | 20 (24.7)% | 25 |
| Neck And Arm Pain | 9 (5.0%) | 13 | 7 (8.6%) | 17 |
| Neurological | 121 (67.6%) | 401 | 52 (64.2%) | 215 |
| Upper Extremity – Sensory | 67 (37.4%) | 175 | 32 (39.5%) | 126 |
| Upper Extremity – Motor | 26 (14.5%) | 43 | 15 (18.5%) | 20 |
| Upper Extremity – Reflex | 18 (10.1%) | 44 | 7 (8.6%) | 20 |
| Lower Extremity – Sensory | 11 (6.1%) | 22 | 2 (2.5%) | 3 |
| Lower Extremity – Motor | 6 (3.4%) | 9 | 4 (4.9%) | 4 |
| Lower Extremity – Reflex | 0 (0.0%) | 0 | 1 (1.2%) | 1 |
| Upper & Lower Extremity - Sensory | 1 ( 0.6%) | 1 | 1 (1.2%) | 1 |
| Upper & Lower Extremity – Motor | 0 | 0 | 0 | 0 |
| Upper & Lower Extremity - Reflex | 0 | 0 | 0 | 0 |
| Neck | 41 (22.9%) | 51 | 21 (25.9%) | 21 |
| Back | 7 (3.9%) | 8 | 2 (2.5%) | 2 |
| Spinal Cord Disturbance | 0 | 0 | 0 | 0 |
| Gait Disturbance | 1 (0.6%) | 1 | 1 (1.2%) | 1 |
| Non Specific | 6 (3.4%) | 6 | 1 (1.2%) | 1 |
| Other* | 35 (19.6%) | 41 | 8 (9.9%) | 15 |
| Non-Union | 0 (0.0%) | 0 | 4 (4.9%) | 4 |
| Other** | 77 (43.0%) | 114 | 33 (40.7%) | 66 |
| Other Pain | 102 (57.0%) | 226 | 47 (58.0%) | 144 |
| Shoulder | 39 (21.8%) | 55 | 21 (25.9%) | 31 |
| Back | 44 (24.6%) | 50 | 18 ( 22.2%) | 30 |
| Torso | 5 (2.8%) | 7 | 3 (3.7%) | 4 |
| Lower Extremity | 26 (14.5%) | 40 | 12 (14.8%) | 29 |
| Headache | 45 (25.1%) | 58 | 26 (32.1%) | 41 |
| Otherr*** | 15 (8.4%) | 16 | 8 (9.9%) | 9 |
| Respiratory | 6 (3.4%) | 6 | 6 (7.4%) | 8 |
| Spinal Disorder | 6 (3.4%) | 7 | 10 (12.3%) | 12 |
| Cervical - Study Surgery | 1 (0.6%) | 1 | 2 (2.5%) | 2 |
| Cervical - Non Study Surgery | 5 (2.8%) | 6 | 3 (3.7%) | 3 |
| Non Cervical | 0 (0.0%) | 0 | 5 (6.2%) | 7 |
| Trauma | 47 (26.3%) | 70 | 20 (24.7%) | 38 |
| Upper Extremity Nerve Entrapment | 8 (4.5%) | 9 | 4 (4.9%) | 5 |
| Urogenital | 9 (5.0%) | 11 | 9 (11.1%) | 12 |
| Vascular Intraop | 1 (0.6%) | 1 | 0 (0.0%) | 0 |
| Wound Issue - Non-Infection | 1 (0.6%) | 1 | 3 (3.7%) | 3 |
| Hematoma | 1 (0.6%) | 1 | 3 (3.7%) | 3 |
| Hematoma Evacuation | 0 | 0 | 0 | 0 |
| CSF Leakage | 0 | 0 | 0 | 0 |
M= All Mobi-C Subjects; F = All ACDF Subjects
↵1 Sum of all treatment emergent adverse events experienced in the study for each treatment group.
↵* Neurological Other includes Neurological events not appropriately defined elsewhere in the Neurological category. This includes amnesia, convulsion, facial neurologic events (dysaesthesia, hypoaesthesia), unexplained loss of consciousness, ‘other’ nerve compression, Parkinson's disease, and stroke.
↵** Other includes events not appropriately defined elsewhere. This includes adverse drug reactions, allergies, anemia, anxiety, arthritis, attention deficit disorder, benign neoplasm, blood & lymphatic system disorders, complications from other medical procedures, congenital defects, dehydration, dermatitis, diabetes, dizziness, ear/eye disorders, endocrine disorders, fatigue, feeling hot, fever, gout, high/low cholesterol, immune system disorders, injury/poisoning, lupus, menopause, miscarriage, muscle atrophy, nutritional disorders, obesity, osteoarthritis, osteoporosis, other inflammation, other medical procedures, plantar fasciitis, polyps, pregnancy, psychiatric disorders, rotator cuff syndrome, skin disorders, sinus infection, social issues, sleep disorders, swelling, tendonitis, thyroid conditions, vascular disorders, and weight gain/loss.
↵*** Other Pain Other includes events not appropriately defined elsewhere. This includes facial pain, fibromyalgia, muscle soreness, chronic pain, nerve pain and arthritis.