MAUDE manufacturer profile

SYNTHES GMBH · FZX

MAUDE profile for Guide, Surgical, Instrument

Key facts

Manufacturer SYNTHES GMBH
Manufacturer group MONUMENT
Product code FZX
Product code name Guide, Surgical, Instrument

At a glance

  • 1,000+ MAUDE reports
  • 100–999 Injury reports
  • 1,000+ Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Device-Device Incompatibility, Break, Material Deformation, Insufficient Information, Material Twisted/Bent, No Known Impact Or Consequence To Patient, Foreign Body In Patient 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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