MAUDE manufacturer profile
STRYKER INSTRUMENTS-KALAMAZOO · EIA
MAUDE profile for Unit, Operative Dental
Key facts
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
|---|---|
| Manufacturer group | STRYKER INSTRUMENTS-KALAMAZOO |
| Product code | EIA |
| Product code name | Unit, Operative Dental |
At a glance
- 1,000+ MAUDE reports
- 10–99 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Patient Involvement, Device Markings/Labelling Problem, Overheating of Device, Device Displays Incorrect Message, Positioning Problem, Unintended Power Up, No Known Impact Or Consequence To Patient, Device Remains Activated 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