MAUDE manufacturer profile
K2M, INC. · MNI
MAUDE profile for Orthosis, Spinal Pedicle Fixation
Key facts
| Manufacturer | K2M, INC. |
|---|---|
| Manufacturer group | K2M, INC. |
| Product code | MNI |
| Product code name | Orthosis, Spinal Pedicle Fixation |
At a glance
- 100–999 MAUDE reports
- 100–999 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Information, Break, Fracture, No Code Available, Insufficient Information, Migration or Expulsion of Device, Injury, Migration 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