ACE 9231323Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00614950002559), received between Mar 28, 2016 and Nov 28, 2016 — classified as 2 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 28, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY WAS REPORTED. NO OSSEOINTEGRATION OF THE IMPLANT MORE THAN 1 TO 5 YEARS AFTER FINAL RESTORATION. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE I. PRIMARY STABILITY WAS ACHIEVED. PATIENT HAS DIABETES.

  Patient problems: Failure of Implant

  MAUDE report 6130151 ↗
• InjuryMar 28, 2016Osseointegration Problem; Osseointegration Problem

  BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS TYPE II. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. 1-5 YEARS AFTER RESTORATION. MOBILITY WAS REPORTED. PATIENT IS A SMOKER. POOR ORAL HYGIENE.

  Patient problems: Failure of Implant

  MAUDE report 5528742 ↗