MAUDE manufacturer profile
MDT SOFAMOR DANEK PUERTO RICO MFG · KWP
MAUDE profile for Appliance, Fixation, Spinal Interlaminal
Key facts
| Manufacturer | MDT SOFAMOR DANEK PUERTO RICO MFG |
|---|---|
| Manufacturer group | MDT SOFAMOR DANEK PUERTO RICO MFG |
| Product code | KWP |
| Product code name | Appliance, Fixation, Spinal Interlaminal |
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 Known Impact Or Consequence To Patient, Failure to Align, No Clinical Signs, Symptoms or Conditions, Break, Device Slipped, Pain, Migration or Expulsion of Device, No Code Available 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