MAUDE manufacturer profile
MEDTRONIC SOFAMOR DANEK USA, INC · HWC
MAUDE profile for Screw, Fixation, Bone
Key facts
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
|---|---|
| Manufacturer group | MEDTRONIC SOFAMOR DANEK USA, INC |
| Product code | HWC |
| Product code name | Screw, Fixation, Bone |
At a glance
- 10–99 MAUDE reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Code Available, Break, Pain, Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, Migration or Expulsion of Device, Loosening of Implant Not Related to Bone-Ingrowth, No Known Impact Or Consequence To Patient 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