MAUDE manufacturer profile
SYNTHES GMBH · NKB
MAUDE profile for Thoracolumbosacral Pedicle Screw System
Key facts
| Manufacturer | SYNTHES GMBH |
|---|---|
| Manufacturer group | MONUMENT |
| Product code | NKB |
| Product code name | Thoracolumbosacral Pedicle Screw System |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 1,000+ Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Pain, No Code Available, Failure of Implant, Impaired Healing, Nonunion/Delayed-union Bone Fracture, Break, No Known Impact Or Consequence To Patient 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