miniMark Dental Implant System 10291020Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00614950003143), received between Apr 8, 2016 and Nov 30, 2023 — classified as 10 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 30, 2023Failure to Osseointegrate; Failure to Osseointegrate

  MOBILITY DISCOVERED AFTER 1 MONTH & IMPLANT REMOVED.

  Patient problems: Failure of Implant

  MAUDE report 18242893 ↗
• InjuryJul 16, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  MOBILITY AND MILD INFLAMMATION WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS TYPE II. 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.

  Patient problems: Failure of Implant

  MAUDE report 8792499 ↗
• InjuryJun 18, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  PERI-IMPLANTITIS, FISTULA, ASINTOMATICA, PAIN, BLEEDING AND NUMBNESS WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS UP TO 1 YEAR AFTER PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED.

  Patient problems: Failure of Implant; Numbness; Pain

  MAUDE report 8707998 ↗
• InjuryJun 18, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  NUMBNESS, PAIN, BLEEDING, SWELLING, FISTULA WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS UP TO 1 YEAR AFTER PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED.

  Patient problems: Failure of Implant; Fistula; Pain; Patient Problem/Medical Problem

  MAUDE report 8707996 ↗
• InjuryJan 10, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 8235022 ↗
• InjuryAug 27, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  PAIN, SWELLING, MOBILITY WERE REPORTED. BONE QUALITY AT TIME OF IMPLANT FAILURE TYPE II. 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.

  Patient problems: Failure of Implant; Pain; Swelling

  MAUDE report 7817774 ↗
• InjuryOct 24, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT WAS TYPE IV. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS 1-3 MONTHS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. PATIENT HAS PERI-IMPLANTIS.

  Patient problems: Failure of Implant

  MAUDE report 6052069 ↗
• InjuryJun 1, 2016Osseointegration Problem; Osseointegration Problem

  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 5692868 ↗
• InjuryJun 1, 2016Osseointegration Problem; Osseointegration Problem

  PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE RESTORATION. IT WAS ALSO REPORTED THE IMPLANT WAS NOT LONG ENOUGH.

  Patient problems: Failure of Implant

  MAUDE report 5692858 ↗
• InjuryApr 8, 2016Osseointegration Problem; Osseointegration Problem

  PAIN AND MOBILITY WAS REPORTED. PRIMARY STABILITY WAS ACHIEVED BUT OSSEOINTEGRATION WAS NOT. AUGMENTATION PROCEDURE WAS PERFORMED AT THE TIME OF SURGERY. INADEQUATE BONE QUALITY.

  Patient problems: Failure of Implant

  MAUDE report 5564140 ↗