MAUDE manufacturer profile
ASCENSION ORTHOPEDICS, INC. · OMX
MAUDE profile for High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis
Key facts
| Manufacturer | ASCENSION ORTHOPEDICS, INC. |
|---|---|
| Manufacturer group | ASCENSION ORTHOPEDICS, INC. |
| Product code | OMX |
| Product code name | High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis |
At a glance
- 100–999 MAUDE reports
- 100–999 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Loosening of Implant Not Related to Bone-Ingrowth, Inadequate Osseointegration, Loss of Range of Motion, Joint Dislocation, Deformity/ Disfigurement, Migration, Device Dislodged or Dislocated 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