miniMark Dental Implant System 09270703Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00614950002863), received between Jun 17, 2016 and Aug 1, 2019 — classified as 8 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 1, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  PAIN, SWELLING AND PERI-IMPLANTITIS WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE III. 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 A BLOOD CLOTTING DISORDER.

  Patient problems: Failure of Implant; Pain

  MAUDE report 8849816 ↗
• InjuryJan 4, 2019Osseointegration Problem; Patient Device Interaction Problem; Osseointegration Problem; Patient Device Interaction Problem

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

  Patient problems: Failure of Implant; Pain; Swelling; Unspecified Infection

  MAUDE report 8216497 ↗
• InjuryNov 15, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  MOBILITY AND PAIN WERE 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 WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 8073118 ↗
• InjurySep 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MOBILITY, PAIN, SWELLING AND PERI-IMPLANTITIS WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. PRIMARY STABILITY WAS ACHIEVED.

  Patient problems: Failure of Implant; Pain; Swelling

  MAUDE report 7878757 ↗
• InjuryMay 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ASINTOMATICA WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. 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 AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 7538656 ↗
• InjurySep 22, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  BONE QUALITY AT THE 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 PERFORMED AT THE TIME OF SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 6888462 ↗
• InjuryNov 7, 2016Osseointegration Problem; Osseointegration Problem

  BONE FRACTURE WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II.

  Patient problems: Failure of Implant

  MAUDE report 6083439 ↗
• InjuryJun 17, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY WAS REPORTED. NO OSSEOINTEGRATION IN 1-3 MONTHS.

  Patient problems: Failure of Implant

  MAUDE report 5732355 ↗