MAUDE manufacturer profile

BIOMET MICROFIXATION · GWO

MAUDE profile for Plate, Cranioplasty, Preformed, Alterable

Key facts

Manufacturer BIOMET MICROFIXATION
Manufacturer group BIOMET MICROFIXATION
Product code GWO
Product code name Plate, Cranioplasty, Preformed, Alterable

At a glance

  • 10–99 MAUDE reports
  • 10–99 Injury reports
  • 1–9 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, No Consequences Or Impact To Patient, Fracture, Insufficient Information, Unspecified Infection, No Information, Necrosis, No Clinical Signs, Symptoms or Conditions 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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