miniMark Dental Implant System 09270704Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00614950002870), received between Dec 22, 2015 and Oct 23, 2017 — classified as 4 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 6969287 ↗
• InjuryOct 23, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  PAIN WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. FRACTURE OF THE IMPLANT WAS ALSO REPORTED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 6969283 ↗
• InjuryDec 14, 2016Osseointegration Problem; Osseointegration Problem

  PAIN AND MOBILITY WAS REPORTED. NO OSSEOINTEGRATION OF THE IMPLANT 3-6 MONTHS BEFORE DISCOVERY. BONE QUALITY AT THE TIME OF IMPLANT SURGERY TYPE II.

  Patient problems: Failure of Implant; Pain

  MAUDE report 6173263 ↗
• InjuryDec 22, 2015Osseointegration Problem

  INFECTION AND MOBILITY WAS REPORTED AT THE TIME OF IMPLANT FAILURE. TIME OF LOSS WAS 0-1 MONTHS BEFORE PROSTHETIC RESTORATION. BONE QUALITY AT TIME OF FAILURE WAS TYPE II.

  Patient problems: Failure of Implant

  MAUDE report 5321053 ↗