EVOS 72465411Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556648643), received between Apr 28, 2023 and Apr 28, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Malposition of Device” (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 16, 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.

• InjuryApr 28, 2023Malposition of Device; Material Deformation; Malposition of Device; Material Deformation

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, AFTER AN ATTEMPT TO POSITION ONE (1) EVOS 2.7/3.5MM PL-D FIB PL 11H R 159MM AND FIXATE A FRACTURE APPROXIMATELY MID SHAFT, WHEN SCREWS WERE PLACED DISTALLY AND SUPERIORITY, IT CAUSED THE FRACTURE TO MAL-REDUCE. IT APPEARS THAT THE TOP THIRD OF THE PLATE SITS FAIRLY OFF THE FIBULA. NO ATTEMPTS WERE MADE TO RE-CONTOUR TO MAKE IT FIT BETTER. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH DOUBLE STACKING 2 SYNTHES 1/3 TUBULAR 11 HOLE PLATES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16829915 ↗