MAUDE manufacturer profile
SYNTHES MONUMENT · HSB
MAUDE profile for Rod, Fixation, Intramedullary And Accessories
Key facts
| Manufacturer | SYNTHES MONUMENT |
|---|---|
| Manufacturer group | SYNTHES MONUMENT |
| Product code | HSB |
| Product code name | Rod, Fixation, Intramedullary And Accessories |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Break, Failure of Implant, Adverse Event Without Identified Device or Use Problem, No Code Available, Nonunion/Delayed-union Bone Fracture, No Known Impact Or Consequence To Patient, Pain, Device Operates Differently Than Expected 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