MAUDE manufacturer profile

SYNTHES BETTLACH · HWA

MAUDE profile for Impactor

Key facts

Manufacturer SYNTHES BETTLACH
Manufacturer group SYNTHES BETTLACH
Product code HWA
Product code name Impactor

At a glance

  • 100–999 MAUDE reports
  • 10–99 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Known Impact Or Consequence To Patient, Break, No Patient Involvement, Mechanical Jam, Device Operates Differently Than Expected, Detachment of Device or Device Component, Material Fragmentation, Loose or Intermittent Connection 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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