MAUDE manufacturer profile
MEDTRONIC SOFAMOR DANEK USA, INC · KWP
MAUDE profile for Appliance, Fixation, Spinal Interlaminal
Key facts
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
|---|---|
| Manufacturer group | MEDTRONIC SOFAMOR DANEK USA, INC |
| Product code | KWP |
| Product code name | Appliance, Fixation, Spinal Interlaminal |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 1,000+ Injury reports
- 100–999 Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- Break, No Known Impact Or Consequence To Patient, No Code Available, Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, Pain, Migration or Expulsion of Device, Unspecified Infection 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