MAUDE manufacturer profile
MEDTRONIC SOFAMOR DANEK USA, INC. · HWE
MAUDE profile for Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Key facts
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC. |
|---|---|
| Manufacturer group | MEDTRONIC SOFAMOR DANEK USA, INC. |
| Product code | HWE |
| Product code name | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment |
At a glance
- 100–999 MAUDE reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Material Twisted/Bent, Break, Mechanical Problem, Device Embedded In Tissue or Plaque, Material Deformation, No Known Impact Or Consequence To Patient, Device Handling Problem 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