Table 4. Adverse events in total population over twelve months .
MedDRA code low level terms | Count of MAST™ related | Count of total related to device, surgery, or MAST™ (serious event) |
Acute allergic reaction | 0 | 1 (1)* |
Back pain | 0 | 7(1)* |
Confusion postoperative | 0 | 1 (1)* |
Dural tear | 0 | 4 |
Fever | 0 | 2 |
Hypoesthesia | 0 | 3 |
Implant site seroma | 0 | 2 |
Implant site abcess | 0 | 1 |
Leg pain | 3 (1)* | 10 (3)* |
Lumbar disc herniation | 0 | 1 (1)* |
Lumbar radiculopathy | 0 | 3 |
Nausea | 0 | 4 |
Sacro-iliac pain | 0 | 4 |
Spinal hematoma | 0 | 1 (1)* |
Urinary tract infection | 0 | 3 |
Urosepsis | 0 | 1 (1)* |
Vertigo | 0 | 1 |
Vomiting | 0 | 1 |
Total | 3(1) | 50 (9) |