MAUDE manufacturer profile

SYNTHES GMBH · NDN

MAUDE profile for Cement, Bone, Vertebroplasty

Key facts

Manufacturer SYNTHES GMBH
Manufacturer group MONUMENT
Product code NDN
Product code name Cement, Bone, Vertebroplasty

At a glance

  • 1,000+ MAUDE reports
  • 1–9 Death reports
  • 100–999 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Improper Chemical Reaction, Fluid/Blood Leak, Inflation Problem, Material Integrity Problem, Insufficient Information, Failure to Eject, Adverse Event Without Identified Device or Use 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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