MAUDE manufacturer profile

STRYKER INSTRUMENTS-KALAMAZOO · GFA

MAUDE profile for Blade, Saw, General & Plastic Surgery, Surgical

Key facts

Manufacturer STRYKER INSTRUMENTS-KALAMAZOO
Manufacturer group STRYKER INSTRUMENTS-IRELAND
Product code GFA
Product code name Blade, Saw, General & Plastic Surgery, Surgical

At a glance

  • 100–999 MAUDE reports
  • 10–99 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Break, No Consequences Or Impact To Patient, Fracture, No Patient Involvement, No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Radiation Exposure, Unintended, Packaging Problem 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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