MAUDE manufacturer profile

MDT SOFAMOR DANEK PUERTO RICO MFG · OVE

MAUDE profile for Intervertebral Fusion Device With Integrated Fixation, Cervical

Key facts

Manufacturer MDT SOFAMOR DANEK PUERTO RICO MFG
Manufacturer group MDT SOFAMOR DANEK PUERTO RICO MFG
Product code OVE
Product code name Intervertebral Fusion Device With Integrated Fixation, Cervical

At a glance

  • 100–999 MAUDE reports
  • 10–99 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, Crack, No Consequences Or Impact To Patient, Fracture, Adverse Event Without Identified Device or Use Problem, 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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