REUNION 5569-P-2011Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327098112), received between Jun 19, 2023 and Jun 19, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryJun 19, 2023Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT COMPLAINED OF RUBBING AND GRINDING IN THEIR ARM AND THE DOCTOR SAID IT WOULD GET BETTER. THE PATIENT SAYS THAT THEIR CONDITION HAS GOTTEN WORSE. THE PATIENT CANNOT USE THEIR ARM AND/OR RAISE IT ABOVE THEIR HEAD. PATIENT WANTS THEIR ARM FIXED AND IS SEEKING COMPENSATION. "EQUIPMENT" HAS COME APART IN PATIENT'S ARM. PATIENT MIGHT NEED A REVISION. CT SCAN IS SCHEDULED TO DETERMINE IF THERE IS ENOUGH BONE FOR A REVISION. PATIENT CANNOT WORK AND IS ON DISABILITY.

  Patient problems: Discomfort; Joint Dislocation; Loss of Range of Motion

  MAUDE report 17159103 ↗