CERTAIN® BELLATEK® ENCODE® IEHA444Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00844868004608), received between Jul 2, 2020 and Nov 11, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (4 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.

• MalfunctionNov 11, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE IMPLANT AT AN UNKNOWN TOOTH SITE HAD A HEALING ABUTMENT THAT WOULD NOT SEAT. THE PATIENT STATED THAT HER IMPLANT CROWN HAS COME LOOSE MULTIPLE TIMES AND SINCE HER DENTIST CHANGED LOCATION, SHE HAD FOUND ANOTHER DENTIST TO TRY TO SEAT THE CROWN BACK. DR. (B)(6) ATTEMPTED TO SEAT THE CROWN A COUPLE OF TIMES AND WAS UNSUCCESSFUL AND MENTIONED THAT IT COULD BE A MISTAKE FROM THE LAB. THE PATIENT WAS SENT BACK TO THE OFFICE TO REMOVE THE CROWN AND TO PLACE A NEW ENCODE HEALING ABUTMENT TO GET NEW IMPRESSIONS AND CROWN. THE NEW ENCODE WOULD NOT SEAT FULLY. THE IMPLANT WAS REMOVED AND REPLACED. IT WAS UNKNOWN WHY THE NEW ENCODE WOULD NOT SEAT FULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23529125 ↗
• MalfunctionOct 15, 2025Mechanical Problem; Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301137 ↗
• InjuryMar 18, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT PATIENT ALWAYS FELT UNCOMFORTABLE WITH THE IMPLANT AT TOOTH LOCATION #3. THE DENTIST PLACED A HEALING ABUTMENT AND THE SCREW WASN'T TIGHTENING. THE DENTIST RECOMMENDED REMOVAL BECAUSE THE IMPLANT WAS LOOSE. THE IMPLANT WAS REMOVED DUE TO THE HEALING ABUTMENT NOT SEATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21635068 ↗
• MalfunctionMay 13, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE CLINICIAN PLACED HEALING ABUTMENT AND SCREW BROKE OFF INSIDE OF THE IMPLANT. THE SCREW WAS REMOVED AND ANOTHER ENCODE PLACED. TOOTH #3

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19296711 ↗
• InjuryJun 13, 2023Unintended Movement; Unintended Movement

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17121527 ↗
• MalfunctionJun 9, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE HEALING ABUTMENT AT POSITION # 35 (UNIVERSAL) WOULD NOT FULLY SEAT. THE IMPLANT IN POSITION 35(UNIVERSAL) HAD FULLY INTEGRATED WHEN TORQUE TESTED. THE HEALING ABUTMENT WAS TRIED ON OTHER IMPLANTS AND STILL IT WOULD NOT SEAT PROPERLY. ANOTHER HEALING ABUTMENT WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14642942 ↗
• MalfunctionJul 2, 2020Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT CLINICIAN PLACED A SECOND IMPLANT AT SITE 4 WITH INSERTION TORQUE 20NCM. CLINICIAN COMPLETED 2ND STAGE FOR IMPLANT ON (B)(6) 2019 AND TO DOCTOR'S KNOWLEDGE THERE NO ISSUES SEATING THE HEALING ABUTMENT. GENERAL DENTIST SENT PATIENT BACK TO CLINICIAN HIM TO RESEAT THE HEALING ABUTMENT ON (B)(6) 2020 AS IT WAS NOT SEATING BACK IN IMPLANT.

  Patient problems: No Information

  MAUDE report 10226008 ↗