MAUDE manufacturer profile
MEDTRONIC SOFAMOR DANEK USA, INC · MAX
MAUDE profile for Intervertebral Fusion Device With Bone Graft, Lumbar
Key facts
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
|---|---|
| Manufacturer group | MEDTRONIC SOFAMOR DANEK USA, INC |
| Product code | MAX |
| Product code name | Intervertebral Fusion Device With Bone Graft, Lumbar |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Break, No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Adverse Event Without Identified Device or Use Problem, Migration, Pain, Device Embedded In Tissue or Plaque, Migration or Expulsion of Device 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