MAUDE manufacturer profile

MAZOR ROBOTICS LTD · OLO

MAUDE profile for Orthopedic Stereotaxic Instrument

Key facts

Manufacturer MAZOR ROBOTICS LTD
Manufacturer group MAZOR ROBOTICS LTD
Product code OLO
Product code name Orthopedic Stereotaxic Instrument

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, Imprecision, Incorrect, Inadequate or Imprecise Result or Readings, Use of Device Problem, No Known Impact Or Consequence To Patient, Mechanical Problem, Adverse Event Without Identified Device or Use Problem, 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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