MAUDE manufacturer profile
NUVASIVE, INCORPORATED · NKB
MAUDE profile for Thoracolumbosacral Pedicle Screw System
Key facts
| Manufacturer | NUVASIVE, INCORPORATED |
|---|---|
| Manufacturer group | NUVASIVE, INCORPORATED |
| Product code | NKB |
| Product code name | Thoracolumbosacral Pedicle Screw System |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Failure of Implant, Fracture, No Clinical Signs, Symptoms or Conditions, Pain, Adverse Event Without Identified Device or Use Problem, Unintended Movement, Migration or Expulsion of Device, Loosening of Implant Not Related to Bone-Ingrowth 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