MAUDE manufacturer profile
INTEGRA - PRINCETON · GXQ
MAUDE profile for Dura Substitute
Key facts
| Manufacturer | INTEGRA - PRINCETON |
|---|---|
| Manufacturer group | INTEGRA - PRINCETON |
| Product code | GXQ |
| Product code name | Dura Substitute |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Cerebrospinal Fluid Leakage, Unspecified Infection, Lack of Effect, Meningitis, Fever, Hematoma, Cerebral Edema 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