miniMark Dental Implant System 11231100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00614950003396), received between Apr 25, 2019 and May 25, 2023 — 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 18, 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.

• InjuryMay 25, 2023Osseointegration Problem; Osseointegration Problem

  AT THE TIME OF CROWN PLACEMENT, IT WAS HURTING THE PATIENT AND SOME MOBILITY NOTED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 17001994 ↗
• InjuryApr 25, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  BLEEDING, SWELLING, FISTULA AND ASYMPTOMATIC WERE REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant; Fistula; Swelling

  MAUDE report 8548555 ↗