Palodent® Plus Sectional Matrix System 659880Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI D0026598801), received between Nov 3, 2025 and Nov 3, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 3, 2025Break; Break

  IN THIS EVENT IT IS REPORTED THAT A PALODENT PLUS TRIAL KIT - PALODENT RING BROKE DURING USE. THE RING SNAPPED IN HALF, ONE PART WAS RETRIEVED AND OTHER PART OF IT WENT DOWN THE PATIENT'S THROAT. DUE TO THE PATIENT SAYING THAT IT FELT LIKE ONE PART WAS STUCK IN THEIR THROAT EMS WAS REQUESTED. PATIENT WENT TO THE ED AND X-RAYS WERE TAKEN AND FOUND THAT THE PATIENT HAD SWALLOWED THE OTHER HALF. FURTHER INFORMATION REQUESTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23449922 ↗