MAUDE report
MAUDE report 45559: EBI DFS DISTAL RADIUS FIXATOR
Malfunction · received Oct 22, 1996 · EBI MEDICAL SYSTEMS, INC
Key facts
| MDR report key | 45559 |
|---|---|
| Report number | 2242816-1996-00093 |
| Event type | Malfunction |
| Brand name | EBI DFS DISTAL RADIUS FIXATOR |
| Model number | 04000 |
| Catalog number | 040000 |
| Manufacturer | EBI MEDICAL SYSTEMS, INC |
| Product code | HTY |
| Device class | Class II |
| Date received by FDA | Oct 22, 1996 |
| Report date | Oct 21, 1996 |
| Report source | Maude |
At a glance
- None Device problems coded
- 1,000+ MAUDE reports for this product code
- 1–9 MAUDE reports for this brand
- None Death reports for this brand
- 1–9 Injury reports for this brand
- No Adverse event flagged
- Yes Product problem flagged
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE medical device reports
MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.
Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date: