MAUDE manufacturer profile
ORTHOFIX US LLC · NKB
MAUDE profile for Thoracolumbosacral Pedicle Screw System
Key facts
| Manufacturer | ORTHOFIX US LLC |
|---|---|
| Manufacturer group | ORTHOFIX, LLC |
| 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
- 10–99 Problems flagged by Orca1 signal analytics
- Break, No Known Impact Or Consequence To Patient, Failure of Implant, No Code Available, Loose or Intermittent Connection, Loosening of Implant Not Related to Bone-Ingrowth, Pain, Device Slipped 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