MAUDE manufacturer profile
AURORA SPINE, INC. · PEK
MAUDE profile for Spinous Process Plate
Key facts
| Manufacturer | AURORA SPINE, INC. |
|---|---|
| Manufacturer group | AURORA SPINE, INC. |
| Product code | PEK |
| Product code name | Spinous Process Plate |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Detachment of Device or Device Component, Break, Sticking, No Consequences Or Impact To Patient, Difficult to Remove, Device Dislodged or Dislocated, Mechanical Problem 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