CERTAIN® ILPAC4530Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00844868037620), received between Nov 9, 2021 and Nov 9, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Separation 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. 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.

• InjuryNov 9, 2021Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE ABUTMENT GOT STUCK TO THE IMPLANT AND COULD NOT GET IT OUT SO THE IMPLANT AT TOOTH SITE #6 WAS REMOVED. PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT AND ABUTMENT. AS A RESULT OF THIS EVENT, NO INJURY TO THE PATIENT REPORTED. SYMPTOMS AS A RESULT OF THE EVENT: NONE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12784074 ↗
• MalfunctionNov 9, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE ABUTMENT SCREW WAS LOOSE SO THEY REMOVED THE SCREW AND REPLACED WITH A NEW ABUTMENT SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12784073 ↗