MAUDE manufacturer profile
MEDTRONIC SOFAMOR DANEK USA, INC · OSH
MAUDE profile for Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Key facts
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
|---|---|
| Manufacturer group | MEDTRONIC SOFAMOR DANEK USA, INC |
| Product code | OSH |
| Product code name | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
At a glance
- 1–9 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- Break, Adverse Event Without Identified Device or Use Problem, Spinal Column Injury, Bone Fracture(s), No Code Available, Pain, No Known Impact Or Consequence To Patient, Loosening of Implant Not Related to Bone-Ingrowth 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