TriLeap Lower Extremity Anatomic Plating System Depth Gauge for 2.0 ScrewsRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810112592719), received between Oct 18, 2024 and Oct 18, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE SALES REPRESENTATIVE DETECTED THAT THE COLOUR BAND FROM A DEPTH GAUGE HOUSING WAS PEELING OFF. THE PRODUCT WAS DISPLAYED IN A TRILEAP DEMO SET IN A MEETING ROOM, IN THE MANUFACTURER CAMPUS. THE DEMO SET WAS SHIPPED TO THE CAMPUS FOR A MEETING WITH AND EXPERT GROUP MEETING. THERE WAS NO PATIENT INVOLVEMENT,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20481101 ↗