MAUDE manufacturer profile
OPTIMIZED ORTHO PTY LTD · PBF
MAUDE profile for Orthopaedic Surgical Planning And Instrument Guides
Key facts
| Manufacturer | OPTIMIZED ORTHO PTY LTD |
|---|---|
| Manufacturer group | OPTIMIZED ORTHO PTY LTD |
| Product code | PBF |
| Product code name | Orthopaedic Surgical Planning And Instrument Guides |
At a glance
- 100–999 MAUDE 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, Inadequate Osseointegration, Use of Device Problem, Unspecified Infection, Joint Dislocation, Bacterial Infection, Joint Laxity, Pain 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