miniMark Dental Implant System 10321005Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00614950003259), received between Jun 13, 2016 and Mar 29, 2017 — 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.

• InjuryMar 29, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PAIN AND MOBILITY WERE REPORTED. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. PATIENT HAS ALLERGIES.

  Patient problems: Failure of Implant; Pain

  MAUDE report 6442432 ↗
• InjuryNov 29, 2016Osseointegration Problem; Osseointegration Problem

  PAIN AND MOBILITY WAS REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVE. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE I. DOCTOR STATES THE IMPLANT DID NOT INTEGRATE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 6133335 ↗
• InjuryJun 13, 2016Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Failure of Implant

  MAUDE report 5720620 ↗