MAUDE manufacturer profile
MEDTRONIC SOFAMOR DANEK USA, INC · GEI
MAUDE profile for Electrosurgical, Cutting & Coagulation & Accessories
Key facts
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
|---|---|
| Manufacturer group | MEDTRONIC SOFAMOR DANEK USA, INC |
| Product code | GEI |
| Product code name | Electrosurgical, Cutting & Coagulation & Accessories |
At a glance
- 10–99 MAUDE reports
- 1–9 Death 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, Pain, Break, No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Hematoma, Nerve Damage, Sepsis 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