MAUDE manufacturer profile

WRIGHTS LANE SYNTHES USA PRODUCTS LLC · MNI

MAUDE profile for Orthosis, Spinal Pedicle Fixation

Key facts

Manufacturer WRIGHTS LANE SYNTHES USA PRODUCTS LLC
Manufacturer group ELMIRA
Product code MNI
Product code name Orthosis, Spinal Pedicle Fixation

At a glance

  • 100–999 MAUDE reports
  • 100–999 Injury reports
  • 1–9 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, Appropriate Term / Code Not Available, Intervertebral Disc Compression or Protrusion, Nonunion/Delayed-union Bone Fracture, Neuralgia, Spinal Cord Injury, Post Operative Wound Infection, Physical Asymmetry 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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