MAUDE manufacturer profile

AUGMENIX, INC. · OVB

MAUDE profile for Hydrogel Spacer

Key facts

Manufacturer AUGMENIX, INC.
Manufacturer group AUGMENIX, INC.
Product code OVB
Product code name Hydrogel Spacer

At a glance

  • 100–999 MAUDE reports
  • 1–9 Death reports
  • 10–99 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Positioning Problem, Adverse Event Without Identified Device or Use Problem, Pain, No Consequences Or Impact To Patient, Fistula, Discomfort, Abscess, 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

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