MAUDE manufacturer profile

MEDTRONIC SOFAMOR DANEK USA, INC. · NVR

MAUDE profile for Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

Key facts

Manufacturer MEDTRONIC SOFAMOR DANEK USA, INC.
Manufacturer group MEDTRONIC SOFAMOR DANEK USA, INC.
Product code NVR
Product code name Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

At a glance

  • 1–9 MAUDE reports
  • 1–9 Injury reports
  • 1–9 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, No Code Available, Pneumothorax, Unspecified Infection, Pain, Swelling, Low Oxygen Saturation 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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