MAUDE manufacturer profile
TUTOGEN MEDICAL GMBH · GXQ
MAUDE profile for Dura Substitute
Key facts
| Manufacturer | TUTOGEN MEDICAL GMBH |
|---|---|
| Manufacturer group | RTI SURGICAL, INC. D/B/A EVERGEN |
| Product code | GXQ |
| Product code name | Dura Substitute |
At a glance
- 10–99 MAUDE reports
- 10–99 Injury reports
- 10–99 Problems flagged by Orca1 signal analytics
- Cerebrospinal Fluid Leakage, Adverse Event Without Identified Device or Use Problem, Material Puncture/Hole, Insufficient Information, Unspecified Infection, Material Disintegration, Inflammation, Degraded 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