CERTAIN® BELLATEK® ENCODE® IEEHA443Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00844868045458), received between Aug 2, 2023 and Aug 12, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (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, 2024Positioning Failure; Positioning Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19965873 ↗
• MalfunctionAug 2, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE HEALING ABUTMENT DID NOT SEAT PROPERLY ON THE IMPLANT. THE DOCTOR PLACED AN IMPLANT AT TOOTH SITE #13. THEN TRIED TO PLACE A HEALING ABUTMENT, BUT CONFIRMED VIA PERI-APICAL THAT IT WAS NOT COMPLETELY SEATED. AS THE DOCTOR TRIED TO BACK THE HEALING ABUTMENT OUT, THE IMPLANT BACKED OUT WITH IT. THE HEALING ABUTMENT APPEARS TO BE "COLD WELDED" TO THE IMPLANT AS THE DOCTOR WAS NOT ABLE TO REMOVE THE HEALING ABUTMENT FROM THE IMPLANT. A NEW IMPLANT WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17445662 ↗