MAUDE manufacturer profile
MEDTRONIC SOFAMOR DANEK USA, INC · NEK
MAUDE profile for Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
Key facts
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
|---|---|
| Manufacturer group | MEDTRONIC SOFAMOR DANEK USA, INC |
| Product code | NEK |
| Product code name | Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 1,000+ Injury reports
- 10–99 Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Injury, Pain, Neuropathy, Numbness, Ambulation Difficulties, Stenosis, Neck 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