CERTAIN® BELLATEK® ILDAT5Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00844868031413), received between Mar 1, 2021 and Jan 28, 2022 — classified as 3 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. 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.

• MalfunctionJan 28, 2022Unintended Movement; Unintended Movement

  ABUTMENT WHEN ANTICALLY PLACED WAS FINE. SINCE RECEIVING ABUTMENT ¿ THEY¿VE HAD TO REPLACE THE SCREW A FEW TIMES. NOW THE ABUTMENT ROCKS & IS NOT SEATING AT ALL PROPERLY. PATIENT CALLED AND REPORTED IT IS ALREADY LOOSE AGAIN. SCHEDULED TO TIGHTEN IT AND DISCUSS NEXT STEPS. SALES REP REPORTED THE ABUTMENT DOES SEAT, BUT IT WILL NOT STAY SEATED. IT LOOSENS UP EVERY FEW WEEKS DESPITE USING A NEW SCREW OR NOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13384800 ↗
• MalfunctionAug 20, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE ABUTMENT WILL NOT STAY IN MOUTH, NOT JUST THE SCREW, BUT THE ABUTMENT. THE PATIENT IS BEING REFERRED TO THE SURGEON TO REVIEW THE IMPLANT. TOOTH- 19.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12350810 ↗
• MalfunctionMar 1, 2021Unintended Movement; Unintended Movement

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11392741 ↗