MAUDE manufacturer profile
SKELETAL DYNAMICS INC. · OZI
MAUDE profile for Internal Hinged Elbow Fixator
Key facts
| Manufacturer | SKELETAL DYNAMICS INC. |
|---|---|
| Manufacturer group | SKELETAL DYNAMICS INC. |
| Product code | OZI |
| Product code name | Internal Hinged Elbow Fixator |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Failure of Implant, Detachment of Device or Device Component, Fracture, Joint Laxity, Mechanical Problem, Off-Label Use, Installation-Related Problem, Break 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