MAUDE manufacturer profile

SYNTHES GMBH · HWC

MAUDE profile for Screw, Fixation, Bone

Key facts

Manufacturer SYNTHES GMBH
Manufacturer group MONUMENT
Product code HWC
Product code name Screw, Fixation, Bone

At a glance

  • 1,000+ MAUDE reports
  • 10–99 Death reports
  • 1,000+ Injury reports
  • 1,000+ Malfunction reports
  • 100–999 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, Break, Nonunion/Delayed-union Bone Fracture, No Clinical Signs, Symptoms or Conditions, Pain, Failure of Implant, Unspecified Infection, Insufficient Information 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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