MAUDE manufacturer profile
XTANT MEDICAL HOLDINGS, INC. · NKB
MAUDE profile for Thoracolumbosacral Pedicle Screw System
Key facts
| Manufacturer | XTANT MEDICAL HOLDINGS, INC. |
|---|---|
| Manufacturer group | XTANT MEDICAL HOLDINGS, INC. |
| Product code | NKB |
| Product code name | Thoracolumbosacral Pedicle Screw System |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Break, Material Fragmentation, Pain, Fracture, Deformation Due to Compressive Stress, Labelling, Instructions for Use or Training Problem, Limb Pain 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