miniMark Dental Implant System 10231040Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00614950003051), received between Apr 8, 2016 and Apr 24, 2020 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MOBILITY AND ASYMPTOMATIC WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION 1 TO 5 YEARS AFTER PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED.

  Patient problems: Failure of Implant

  MAUDE report 9995498 ↗
• InjuryApr 8, 2016Osseointegration Problem; Osseointegration Problem

  PAIN AND MOBILITY WAS REPORTED. PRIMARY STABILITY WAS ACHIEVED BUT OSSEOINTEGRATION WAS NOT. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. PATIENT IS A SMOKER.

  Patient problems: Failure of Implant

  MAUDE report 5564156 ↗
• InjuryApr 8, 2016Osseointegration Problem; Osseointegration Problem

  PAIN AND MOBILITY WAS REPORTED. PRIMARY STABILITY WAS ACHIEVED BUT OSSEOINTEGRATION WAS NOT. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. PATIENT IS A SMOKER.

  Patient problems: Failure of Implant

  MAUDE report 5564134 ↗