Table 7. Adverse Events (AEs) and serious adverse events (SAEs) in Total Population.
| MedDRA code low level terms | Count of MAST procedure related | Count of total related to device OR surgery OR MAST (serious event) |
|---|---|---|
| Acute allergic reaction | 1 (1) | |
| Back pain | 4 (1) | |
| Confusion postoperative | 1 (1) | |
| Dural tear | 4 | |
| Fever | 2 | |
| Hypoesthesia | 3 | |
| Implant site seroma | 2 | |
| Incision site abscess | 1 | |
| Leg pain | 1 | 6 (1) |
| Lumbar radiculopathy | 3 | |
| Nausea | 4 | |
| Sacro-iliac pain | 1 | |
| Spinal hematoma | 1 (1) | |
| Urinary tract infection | 3 | |
| Urosepsis | 1 (1) | |
| Vertigo | 1 | |
| Vomiting | 1 | |
| Total | 1 | 39 (6) |