MAUDE manufacturer profile
SYNTHES GMBH · GXN
MAUDE profile for Plate, Cranioplasty, Preformed, Non-Alterable
Key facts
| Manufacturer | SYNTHES GMBH |
|---|---|
| Manufacturer group | WERK MEZZOVICO (CH) |
| Product code | GXN |
| Product code name | Plate, Cranioplasty, Preformed, Non-Alterable |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Unspecified Infection, Defective Device, No Clinical Signs, Symptoms or Conditions, Appropriate Term / Code Not Available, Insufficient Information, No Code Available, Post Operative Wound Infection 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