NA LPC442Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00844868021339), received between Mar 26, 2021 and Aug 12, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2021Unintended Movement; Unintended Movement

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12313069 ↗
• MalfunctionMar 26, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT HE LOW PROFILE ABUTMENT WAS PLACED IN THE IMPLANT AND WAS UPLOADED WITH THE CROWN. PATIENT CAME TO THE CLINIC SOME DAYS LATER DUE TO CROWN MOBILITY. WHEN DOCTOR WAS TRYING TO ADJUST THE CROWN IT WAS NOTICED THAT THE CROWN WAS NOT THE ONE LOOSEN, IT WAS THE LOW PROFILE ABUTMENT. THE LOW PROFILE ABUTMENT CAME OUT WITH THE CROWN SCREWED. THE ABUTMENT HAD BEEN PLACED WITH 20 NCM TORQUE. IT WAS REPLACED WITH OTHER ABUTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11574124 ↗