MAUDE manufacturer profile

INTEGRA LIFESCIENCES(IRELAND) · LBK

MAUDE profile for Neurosurgical Ultrasonic Instruments

Key facts

Manufacturer INTEGRA LIFESCIENCES(IRELAND)
Manufacturer group INTEGRA LIFESCIENCES(IRELAND)
Product code LBK
Product code name Neurosurgical Ultrasonic Instruments

At a glance

  • 10–99 MAUDE reports
  • 1–9 Death reports
  • 10–99 Malfunction reports
  • 1–9 Problems flagged by Orca1 signal analytics
  • No Consequences Or Impact To Patient, Mechanical Problem, No Clinical Signs, Symptoms or Conditions, Pressure Problem, No Patient Involvement, Crack, Overheating of Device, Defective Device 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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