MAUDE manufacturer profile

WARSAW ORTHOPEDICS · NKB

MAUDE profile for Thoracolumbosacral Pedicle Screw System

Key facts

Manufacturer WARSAW ORTHOPEDICS
Manufacturer group WARSAW ORTHOPEDICS
Product code NKB
Product code name Thoracolumbosacral Pedicle Screw System

At a glance

  • 100–999 MAUDE reports
  • 100–999 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Break, No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Pain, No Code Available, Failure to Align, Appropriate Term/Code Not Available, Migration or Expulsion of 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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