MAUDE manufacturer profile
STRYKER INSTRUMENTS-KALAMAZOO · ERL
MAUDE profile for Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Key facts
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
|---|---|
| Manufacturer group | STRYKER INSTRUMENTS-KALAMAZOO |
| Product code | ERL |
| Product code name | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Overheating of Device, No Patient Involvement, No Consequences Or Impact To Patient, No Clinical Signs, Symptoms or Conditions, Device Displays Incorrect Message, No Known Impact Or Consequence To Patient, Device Remains Activated, Unintended Power Up 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