MAUDE brand profile

OPTETRAK TIBIAL STEM EXTENSION SCREW

MAUDE brand safety profile

Key facts

Brand name OPTETRAK TIBIAL STEM EXTENSION SCREW

At a glance

  • 10–99 MAUDE reports
  • 1–9 Injury reports
  • 1–9 Malfunction reports
  • 10–99 Problems coded
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Code Available, Joint Disorder, Loose or Intermittent Connection, Loosening of Implant Not Related to Bone-Ingrowth, Failure of Implant, Adverse Event Without Identified Device or Use Problem, Insufficient Information, Pain Most reported problems

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE brand safety profiles

Brand profiles aggregate every MAUDE report that names the brand, so you can compare report volumes and problem patterns across devices. Reports are unverified and do not by themselves establish causation.

Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1

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