REUNION 5901-E-5220Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327099942), received between Oct 3, 2018 and Mar 19, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (2 reports).

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.

• MalfunctionMar 19, 2019Break; Fracture; Fracture

  UPON INCOMING INSPECTION IT WAS NOTICED THAT THE DEVICE WAS BROKEN AND UNUSABLE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8434714 ↗
• MalfunctionDec 19, 2018Naturally Worn

  UPON INCOMING INSPECTION, ITEM WAS VISIBLY WORN. NO FURTHER INFORMATION IS AVAILABLE. BROKEN INNER PEG.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8182790 ↗
• MalfunctionOct 3, 2018Component Missing; Naturally Worn

  UPON INCOMING INSPECTION, ITEM WAS VISIBLY WORN. BOTH TRIALS WERE MISSING INNER PLASTIC PEG. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7930449 ↗