MAUDE manufacturer profile
MEDTRONIC SOFAMOR DANEK USA, INC · HBE
MAUDE profile for Drills, Burrs, Trephines & Accessories (Simple, Powered)
Key facts
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
|---|---|
| Manufacturer group | MEDTRONIC SOFAMOR DANEK USA, INC |
| Product code | HBE |
| Product code name | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
At a glance
- 100–999 MAUDE reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Break, No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Material Deformation, No Consequences Or Impact To Patient, Device Embedded In Tissue or Plaque, Mechanics Altered, Material Twisted/Bent 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