MAUDE manufacturer profile
ORTHOFIX MEDICAL INC · NKB
MAUDE profile for Thoracolumbosacral Pedicle Screw System
Key facts
| Manufacturer | ORTHOFIX MEDICAL INC |
|---|---|
| Manufacturer group | ORTHOFIX MEDICAL INC |
| Product code | NKB |
| Product code name | Thoracolumbosacral Pedicle Screw System |
At a glance
- 1–9 MAUDE reports
- 1–9 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- Failure of Implant, Loosening of Implant Not Related to Bone-Ingrowth, No Clinical Signs, Symptoms or Conditions, Loose or Intermittent Connection, Leak/Splash, Appropriate Term/Code Not Available, Break, Off-Label Use 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