MAUDE manufacturer profile
BIOMET MICROFIXATION · KKY
MAUDE profile for Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Key facts
| Manufacturer | BIOMET MICROFIXATION |
|---|---|
| Manufacturer group | BIOMET MICROFIXATION |
| Product code | KKY |
| Product code name | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, No Known Impact Or Consequence To Patient, Inadequacy of Device Shape and/or Size, No Code Available, Unspecified Infection, Insufficient Information, No Information, Fracture 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