MAUDE manufacturer profile

MDT SOFAMOR DANEK PUERTO RICO MFG · KWQ

MAUDE profile for Appliance, Fixation, Spinal Intervertebral Body

Key facts

Manufacturer MDT SOFAMOR DANEK PUERTO RICO MFG
Manufacturer group MDT SOFAMOR DANEK PUERTO RICO MFG
Product code KWQ
Product code name Appliance, Fixation, Spinal Intervertebral Body

At a glance

  • 100–999 MAUDE reports
  • 1–9 Death reports
  • 10–99 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Break, No Known Impact Or Consequence To Patient, Migration or Expulsion of Device, Pain, No Clinical Signs, Symptoms or Conditions, Device Embedded In Tissue or Plaque, Migration, No Code Available 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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