MAUDE manufacturer profile
PARAGON 28 · HTW
MAUDE profile for Bit, Drill
Key facts
| Manufacturer | PARAGON 28 |
|---|---|
| Manufacturer group | PARAGON 28 |
| Product code | HTW |
| Product code name | Bit, Drill |
At a glance
- 10–99 MAUDE reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Break, Insufficient Information, No Clinical Signs, Symptoms or Conditions, Detachment of Device or Device Component, Device Embedded In Tissue or Plaque, Failure of Implant, Appropriate Term / Code Not Available, No Apparent Adverse Event 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