ACE 09231322.Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00614950002535), received between Dec 15, 2015 and Mar 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.

• InjuryMar 28, 2016Osseointegration Problem; Osseointegration Problem

  BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS TYPE II. PRIMARY STABILITY WAS ACHIEVED AND OSSEOINTEGRATION WAS NOT. 1-5 YEARS AFTER RESTORATION. MOBILITY WAS REPORTED. PATIENT IS A SMOKER. POOR ORAL HYGIENE.

  Patient problems: Failure of Implant

  MAUDE report 5528756 ↗
• InjuryDec 15, 2015Osseointegration Problem

  BONE LOSS, PAIN AND GRANULATION WAS REPORTED AT TIME OF IMPLANT FAILURE. OTHER CAUSE WAS PERI-IMPLANTITIS.

  Patient problems: Failure of Implant

  MAUDE report 5297403 ↗