MAUDE manufacturer profile
K2M, INC. · NKB
MAUDE profile for Thoracolumbosacral Pedicle Screw System
Key facts
| Manufacturer | K2M, INC. |
|---|---|
| Manufacturer group | K2M, INC. |
| Product code | NKB |
| Product code name | Thoracolumbosacral Pedicle Screw System |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Migration, No Clinical Signs, Symptoms or Conditions, No Information, Fracture, Pain, Migration or Expulsion of Device, Break, Injury 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