MAUDE manufacturer profile
MDT SOFAMOR DANEK PUERTO RICO MFG · NKB
MAUDE profile for Thoracolumbosacral Pedicle Screw System
Key facts
| Manufacturer | MDT SOFAMOR DANEK PUERTO RICO MFG |
|---|---|
| Manufacturer group | MDT SOFAMOR DANEK PUERTO RICO MFG |
| Product code | NKB |
| Product code name | Thoracolumbosacral Pedicle Screw System |
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
- No Clinical Signs, Symptoms or Conditions, Break, No Known Impact Or Consequence To Patient, Pain, Loosening of Implant Not Related to Bone-Ingrowth, Device Dislodged or Dislocated, No Code Available, Material Deformation 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