CERTAIN® BELLATEK® ENCODE® IEEHA355Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00844868045434), received between May 21, 2024 and Jun 18, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (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.

• MalfunctionJun 18, 2024Separation Failure; Separation Failure

  IMPLANT PLACEMENT AT TOOTH SITE #13 WAS REPORTED. AN IMPLANT AND ALSO THE HEALING ABUTMENT WAS PLACED THAT DAY. CLINICIAN COULD NOT SEPARATE THE ABUTMENT FROM THE IMPLANT, UNTIL THE IMPLANT WAS REMOVED FROM THE OSTEOTOMY, AND WHEN THE CLINICIAN HAD SEATED THE ABUTMENT, IT HAD CAUSED THE IMPLANT TO SPIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559024 ↗
• MalfunctionMay 21, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE HEALING ABUTMENT WOULD NOT SEAT INSIDE THE IMPLANT. THE CLINICIAN USED ANOTHER HEALING ABUTMENT WITH THE SAME LOT TO COMPLAINT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19359421 ↗