MAUDE manufacturer profile
DEPUY SYNTHES SPINE · MNI
MAUDE profile for Orthosis, Spinal Pedicle Fixation
Key facts
| Manufacturer | DEPUY SYNTHES SPINE |
|---|---|
| Manufacturer group | MEDOS INTERNATIONAL SARL |
| Product code | MNI |
| Product code name | Orthosis, Spinal Pedicle Fixation |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Break, Injury, Failure of Implant, Adverse Event Without Identified Device or Use Problem, Torn Material, Loose or Intermittent Connection, Sudden Cardiac Death 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