MAUDE manufacturer profile
MEDACTA INTERNATIONAL SA · NKB
MAUDE profile for Thoracolumbosacral Pedicle Screw System
Key facts
| Manufacturer | MEDACTA INTERNATIONAL SA |
|---|---|
| Manufacturer group | MEDACTA INTERNATIONAL SA |
| Product code | NKB |
| Product code name | Thoracolumbosacral Pedicle Screw System |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Fracture, Adverse Event Without Identified Device or Use Problem, Bone Fracture(s), Break, Pain, No Clinical Signs, Symptoms or Conditions, Appropriate Term/Code Not Available Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1