miniMark Dental Implant System 11231000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00614950003389), received between Jun 21, 2016 and Jun 21, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Osseointegration Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 21, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY WAS REPORTED AT TIME OF IMPLANT FAILURE. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. IT WAS REPORTED FAILURE TO ACHIEVE PRIMARY STABILITY AND INADEQUATE BONE QUALITY.

  Patient problems: Failure of Implant

  MAUDE report 5739458 ↗