MAUDE manufacturer profile
SYNTHES GMBH · GXQ
MAUDE profile for Dura Substitute
Key facts
| Manufacturer | SYNTHES GMBH |
|---|---|
| Manufacturer group | MONUMENT |
| Product code | GXQ |
| Product code name | Dura Substitute |
At a glance
- 10–99 MAUDE reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Separation Failure, No Code Available, No Known Impact Or Consequence To Patient, Reaction, Unspecified Infection, Break, Device Operates Differently Than Expected 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