MAUDE manufacturer profile

SYNTHES GMBH · MNI

MAUDE profile for Orthosis, Spinal Pedicle Fixation

Key facts

Manufacturer SYNTHES GMBH
Manufacturer group MONUMENT
Product code MNI
Product code name Orthosis, Spinal Pedicle Fixation

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
  • Adverse Event Without Identified Device or Use Problem, Post Operative Wound Infection, Pain, Nonunion/Delayed-union Bone Fracture, Nerve Damage, Unspecified Tissue Injury, No Code Available, Bone Fracture(s) 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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