CERTAIN® BELLATEK® ENCODE® IEHA466Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00844868004691), received between Jun 30, 2022 and Nov 8, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2024Positioning Failure; Positioning Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20638015 ↗
• MalfunctionFeb 14, 2023Positioning Failure; Positioning Failure

  CUSTOMER REPORTED COULD NOT GET HEALING ABUTMENT TO SEAT. MAYBE STRIPPED. TOOTH 31. ANOTHER PRODUCT WAS USED TO FINISH THE PROCEDURE. THE SITE WAS GRAFTED WITH ALLOGRAFT PRIOR TO ORIGINAL IMPLANT PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16370642 ↗
• MalfunctionJun 30, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE ENCODE HEALING ABUTMENT AT END OF SHAFT THE TIP IS FLARED OUT. THIS DEFECT WOULD NOT ALLOW IT TO SEAT. LAB HAD TO HAD GRIND THE ENCODE HEALING ABUTMENT TO MAKE IT THE CORRECT SHAPE TO FIT. TOOTH SITE # 13.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14873789 ↗