ACE 09231326.Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00614950002580), received between Dec 15, 2015 and Mar 29, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 18, 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.

• InjuryMar 29, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MOBILITY, INFECTION AND BLEEDING WERE REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS 1 TO 5 YEARS AFTER PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 11581166 ↗
• InjuryNov 16, 2020Unintended Movement; Unintended Movement

  MOBILITY WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS 1 TO 5 YEARS AFTER PROSTHETIC RESTORATION.

  Patient problems: Failure of Implant

  MAUDE report 10842612 ↗
• InjurySep 1, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  DISCOMFORT WAS REPORTED. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS 1-5 YEARS AFTER PROSTHETIC RESTORATION.

  Patient problems: Failure of Implant

  MAUDE report 6839366 ↗
• InjuryMar 28, 2016Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Failure of Implant

  MAUDE report 5528918 ↗
• InjuryDec 15, 2015Osseointegration Problem

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

  Patient problems: Failure of Implant

  MAUDE report 5298338 ↗