MAUDE manufacturer profile
PEGA MEDICAL INC. · KTT
MAUDE profile for Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Key facts
| Manufacturer | PEGA MEDICAL INC. |
|---|---|
| Manufacturer group | ORTHOPEDIATRICS CANADA ULC |
| Product code | KTT |
| Product code name | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
At a glance
- 1–9 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Misassembled During Installation, Misassembly by Users, Loosening of Implant Not Related to Bone-Ingrowth, Malposition of Device, Material Separation, Fracture, Detachment of Device or Device Component, Malunion of Bone 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