MAUDE manufacturer profile
MEDTRONIC SOFAMOR DANEK USA, INC · NDN
MAUDE profile for Cement, Bone, Vertebroplasty
Key facts
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
|---|---|
| Manufacturer group | MEDTRONIC SOFAMOR DANEK USA, INC |
| Product code | NDN |
| Product code name | Cement, Bone, Vertebroplasty |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Leak/Splash, No Clinical Signs, Symptoms or Conditions, Extravasation, Appropriate Term/Code Not Available, Coagulation in Device or Device Ingredient, Migration or Expulsion of Device, Adverse Event Without Identified Device or Use 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