MAUDE manufacturer profile
INTEGRA NEUROSCICENCS IMPLANTS SA · GYK
MAUDE profile for Instrument, Shunt System Implantation
Key facts
| Manufacturer | INTEGRA NEUROSCICENCS IMPLANTS SA |
|---|---|
| Manufacturer group | INTEGRA NEUROSCICENCS IMPLANTS SA |
| Product code | GYK |
| Product code name | Instrument, Shunt System Implantation |
At a glance
- 1–9 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- Device Packaging Compromised, Bent, Mechanical Jam, Difficult to Remove, Break, Paresis, Keratitis, Confusion/ Disorientation 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