MAUDE manufacturer profile
MEDTRONIC SOFAMOR DANEK USA, INC · LXH
MAUDE profile for Orthopedic Manual Surgical Instrument
Key facts
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
|---|---|
| Manufacturer group | MEDTRONIC SOFAMOR DANEK USA, INC |
| Product code | LXH |
| Product code name | Orthopedic Manual Surgical Instrument |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Break, Mechanics Altered, No Known Impact Or Consequence To Patient, Mechanical Problem, Optical Problem, Material Deformation, Device Embedded In Tissue or Plaque 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