miniMark Dental Implant System 10231520Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00614950003105), received between May 9, 2016 and Aug 27, 2021 — 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.

• InjuryAug 27, 2021Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  INFECTION WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE I. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. PATIENT HAS DIABETES.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 12378243 ↗
• InjuryJun 17, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS LESS THAN 1 YEAR AFTER THE PLACEMENT. ASYMPTOMATIC WAS ALSO REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 5732538 ↗
• InjuryJun 17, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS LESS THAN 1 YEAR AFTER THE PLACEMENT. ASYMPTOMATIC WAS ALSO REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 5732480 ↗
• InjuryMay 9, 2016Osseointegration Problem; Osseointegration Problem

  IMPLANT FAILURE DUE TO INSUFFICIENT BONE. BONE QUALITY AT TIME OF FAILURE WAS REPORTED AS TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS LESS THAN 1 YEAR AFTER PROSTHETIC PLACEMENT. ASYMPTOMATIC WAS ALSO REPORTED. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED.

  Patient problems: Failure of Implant

  MAUDE report 5641307 ↗