MAUDE manufacturer profile

MEDTRONIC NEUROSURGERY · GXQ

MAUDE profile for Dura Substitute

Key facts

Manufacturer MEDTRONIC NEUROSURGERY
Manufacturer group MEDTRONIC NEUROSURGERY
Product code GXQ
Product code name Dura Substitute

At a glance

  • 100–999 MAUDE reports
  • 1–9 Death reports
  • 100–999 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, Cerebrospinal Fluid Leakage, Headache, Fever, Meningitis, Insufficient Information, Fluid/Blood Leak, Unspecified Infection 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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