EVOS 72468204Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556672846), received between Apr 24, 2019 and Aug 26, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING AN ORIF PROCEDURE, THE LOCKING SCREW FAILED TO ENGAGE WITH THE EVOS VOLAR PLATE 4H R STD 56MM. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A COMPETITOR COMPANY DEVICE. IT IS UNKNOWN IF THE HOLES DRILLED FOR THE S+N PLATES WERE THE SAME USED FOR THE COMPETITOR'S PLATE. PATIENT IS REPORTED TO BE DOING WELL.

  Patient problems: Perforation

  MAUDE report 22892151 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING AN UNKNOWN TRAUMA PROCEDURE, AS THE SCREW WAS BEING SCREWED INTO THE BONE, IT WENT THOROUGH THE PLATE. PROCEDURE FINISHED WITH A COMPETITOR DEVICE. SURGICAL DELAY LESS THAN OR EQUAL TO 30 MINUTES. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10817519 ↗
• InjuryApr 24, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE LOCKING SCREW PASSED THROUGH THE PLATE HOLE COMPLETELY. IN ORDER TO REMOVE THE LOCKING SCREW, THE ENTIRE PLATE WAS REMOVED. THE SURGEON USED THE OLD STYLE PERI-LOC VDR SYSTEM TO COMPLETE THE CASE TO HIS PROPER STANDARDS.

  Patient problems: Injury

  MAUDE report 8547389 ↗