MAUDE manufacturer profile

SYNTHES ELMIRA · HSB

MAUDE profile for Rod, Fixation, Intramedullary And Accessories

Key facts

Manufacturer SYNTHES ELMIRA
Manufacturer group SYNTHES ELMIRA
Product code HSB
Product code name Rod, Fixation, Intramedullary And Accessories

At a glance

  • 100–999 MAUDE reports
  • 1–9 Death reports
  • 100–999 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Failure of Implant, No Code Available, Migration or Expulsion of Device, Adverse Event Without Identified Device or Use Problem, Pain, Unintended Movement, No Known Impact Or Consequence To Patient, Nonunion/Delayed-union Bone Fracture 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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