CERTAIN® LOCATOR® IMLOA005Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00844868006350), received between May 7, 2022 and Sep 9, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2022Fracture; Fracture

  THE DOCTOR REPORTS THAT THE PATIENT GOES TO HIS MEDICAL OFFICE WITH THE PROSTHESIS REMOVED AND THERE THE DOCTOR SHOWS THE LOCATOR BREAKAGE IN THE PART OF THE BODY. THE AFFECTED TOOTH POSITION IS #36. THE DENTAL PROCEDURE WAS NOT COMPLETED WITH ANOTHER ITEM. THE PATIENT DID NOT SUFFER ANY TYPE OF NEGATIVE IMPACT ON HIS HEALTH AS A CONSEQUENCE OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15392860 ↗
• MalfunctionMay 7, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO A FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14317655 ↗