MAUDE manufacturer profile
ALPHATEC SPINE, INC. · NKB
MAUDE profile for Thoracolumbosacral Pedicle Screw System
Key facts
| Manufacturer | ALPHATEC SPINE, INC. |
|---|---|
| Manufacturer group | ALPHATEC SPINE, INC. |
| Product code | NKB |
| Product code name | Thoracolumbosacral Pedicle Screw System |
At a glance
- 100–999 MAUDE reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Failure of Implant, Break, Device Dislodged or Dislocated, Fracture, No Known Impact Or Consequence To Patient, No Code Available, No Clinical Signs, Symptoms or Conditions, Detachment of Device or Device Component 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