miniMark Dental Implant System 10321320Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00614950003334), received between May 10, 2016 and Aug 6, 2021 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  MOBILITY WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS UP TO 1 YEAR AFTER PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 12290882 ↗
• InjuryJun 18, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  PAIN, BLEEDING, SWELLING, NUMBNESS AND FISTULA WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED.

  Patient problems: Failure of Implant; Fistula; Numbness; Pain

  MAUDE report 8707997 ↗
• InjuryMay 10, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. PRIMARY STABILITY WAS ACHIEVED BUT OSSEOINTEGRATION WAS NOT. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 5643628 ↗