CERTAIN® BELLATEK® ENCODE® IEEHA455Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00844868045496), received between Mar 20, 2023 and Sep 25, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Positioning Failure

  It was reported that during the second-stage surgery, the insertion of the Encode Emergence healing screw was impossible. The doctor was unable to screw the device. Tooth site 26.No impact on the patient reported. Procedure was completed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896488 ↗
• MalfunctionApr 17, 2026Positioning Failure

  IT WAS REPORTED THAT THE HEALING ABUTMENT WAS NOT SEATING CORRECTLY ON THE IMPLANT AT TOOTH SITE #28. THE PROCEDURE WAS COMPLETED WITH ANOTHER HEALING ABUTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24916125 ↗
• MalfunctionJan 6, 2026Positioning Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23974484 ↗
• MalfunctionNov 25, 2025Separation Failure; Separation Failure

  NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646875 ↗
• InjuryJan 30, 2025Mechanical Problem; Device Damaged by Another Device; Mechanical Problem; Device Damaged by Another Device

  CONTACTED ORAL SURGEON FOR ADDITIONAL DETAILS. IT WAS REPORTED THAT THE TOP HEX OF THE ENCODE HEALING ABUTMENT WAS STRIPPED. WHILE TRYING TO DRILL IT THE ABUTMENT, THE INTERNAL THREADS OF THE IMPLANT WERE DAMAGED IN THE PROCESS. THE IMPLANT WAS REMOVED AND SITE GRAFTED. PATIENT WILL RETURN LATER TO REPLACE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain

  MAUDE report 21277252 ↗
• MalfunctionMar 20, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE ENCODE HEALING ABUTMENT DID NOT SEAT IN THE PATIENT'S MOUTH. THEY WERE UNABLE TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16573007 ↗
• MalfunctionMar 20, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE ENCODE HEALING ABUTMENT DID NOT SEAT IN THE PATIENT'S MOUTH. THEY WERE UNABLE TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16572990 ↗