EVOS 71158403Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556693810), received between Sep 17, 2020 and Sep 17, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Defective 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.

• InjurySep 17, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A RIGHT ORIF DISTAL RADIUS PROCEDURE, WHILE SURGEON WAS DOING SCREW INSERTION (FIRST TIME FOR THIS PARTICULAR HOLE), THE SCREW PASS THROUGH THE PLATE HOLE, THE SCREW WENT INSIDE PATIENT¿S BONE, IT SEEMS THE HOLE ON THE PLATE HAVE DEFORMED WHEN HE WAS TRYING TO SCREW IN. THE REDUCTION WAS ALREADY DONE SO HE MANAGED TO TURN THE SCREW IN A DIFFERENT ANGLE INSTEAD OF USING A DIFFERENT COMPANY SYSTEM. A DELAY OF LESS THAN 30 MIN REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10551756 ↗