MAUDE manufacturer profile

PARAGON 28 · HSN

MAUDE profile for Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Key facts

Manufacturer PARAGON 28
Manufacturer group PARAGON 28
Product code HSN
Product code name Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

At a glance

  • 10–99 MAUDE reports
  • 1–9 Injury reports
  • 1–9 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, Insufficient Information, Implant Pain, Pain, Bone Fracture(s), Nonunion/Delayed-union Bone Fracture, Appropriate Term / Code Not 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

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