CERTAIN® BELLATEK® ILDAT4Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00844868031406), received between Oct 23, 2020 and May 19, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Mechanical Problem

  IT WAS REPORTED THAT THE GOLD SCREW WAS NOT ABLE TO SEAT ALL THE WAY. THE SCREW WAS LOOSE AND THUS THE WHOLE CROWN/ABUTMENT HAD MOVEMENT. WE WERE ABLE TO RETRIEVE THE GOLD SCREW, BUT THE ABUTMENT WAS LODGED INTO THE IMPLANT AND WOULD NOT COME OUT. THE ABUTMENT AND CROWN HAD TO BE CUT TO BE REMOVED. TOOTH #13. THE IMPLANT IS OK AND I STILL HAVE THE REMAINING CROWN  AND ABUTMENT.. THE ABUT FAILED, AS PER DR ABUTMENT WAS LOOSE, THERE WAS CEMENT IN THE INTERFACE, ABUTMENT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216357 ↗
• MalfunctionDec 5, 2022Unintended Movement; Unintended Movement

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15914454 ↗
• MalfunctionAug 25, 2022Positioning Failure; Mechanical Problem; Positioning Failure; Mechanical Problem

  IT WAS REPORTED THAT THERE WAS DAMAGE TO THE UPPER HEX OF IMPLANT DURING SEATING OF ABUTMENT. COULD NOT SEAT ABUTMENT PROPERLY, HAD TO ORDER ANGLED ABUTMENT AND WILL HAVE TO RE-DO CROWN. TOOTH #19.

  Patient problems: Insufficient Information

  MAUDE report 15292545 ↗
• MalfunctionFeb 14, 2022Unintended Movement; Unintended Movement

  IT IS REPORTED THAT THE ABUTMENT WAS LOOSE IN THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13523264 ↗
• MalfunctionOct 23, 2020Unintended Movement; Unintended Movement

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

  Patient problems: No Information

  MAUDE report 10727767 ↗