MAUDE manufacturer profile
OSSEUS FUSION SYSTEMS, LLC. · MNI
MAUDE profile for Orthosis, Spinal Pedicle Fixation
Key facts
| Manufacturer | OSSEUS FUSION SYSTEMS, LLC. |
|---|---|
| Manufacturer group | OSSEUS FUSION SYSTEMS, LLC. |
| Product code | MNI |
| Product code name | Orthosis, Spinal Pedicle Fixation |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Improper or Incorrect Procedure or Method, No Known Impact Or Consequence To Patient, Difficult To Position, Mechanical Jam, Physical Resistance/Sticking, Material Separation, Defective Device, Inadequacy of Device Shape and/or Size 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