miniMark Dental Implant System 09270702Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00614950002856), received between Dec 14, 2016 and Jun 18, 2019 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  NUMBNESS 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 WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED.

  Patient problems: Failure of Implant; Numbness

  MAUDE report 8707995 ↗
• InjuryJun 18, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  NUMBNESS 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 WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED.

  Patient problems: Failure of Implant; Numbness

  MAUDE report 8707994 ↗
• InjuryJan 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MOBILITY, PAIN, PERI-IMPLANTITIS AND FISTULA 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 AND OSSEOINTEGRATION WAS ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. PATIENT HAS A BLOOD COAGULATION DISORDER.

  Patient problems: Failure of Implant; Fistula; Pain

  MAUDE report 8216495 ↗
• 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 7878751 ↗
• 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 7878748 ↗
• 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 7878741 ↗
• InjuryJan 9, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  PAIN AND FISTULA 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 IS A SMOKER.

  Patient problems: Failure of Implant; Fistula; Pain

  MAUDE report 7174638 ↗
• InjuryJan 9, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  PAIN AND MOBILITY 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. OSSEONTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY. PATIENT IS A SMOKER.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7174637 ↗
• InjuryDec 14, 2016Osseointegration Problem; Osseointegration Problem

  PAIN, MOBILITY AND NO OSSEOINTEGRATION WAS REPORTED. NO OSSEOINTEGRATION OF THE IMPLANT 1-3 MONTHS BEFORE DISCOVERY. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. PATIENT IS A SMOKER.

  Patient problems: Failure of Implant; Pain

  MAUDE report 6173355 ↗
• InjuryDec 14, 2016Osseointegration Problem; Osseointegration Problem

  PAIN, MOBILITY AND NO OSSEOINTEGRATION WAS REPORTED. NO OSSEOINTEGRATION OF THE IMPLANT 1-3 MONTHS BEFORE DISCOVERY. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. PATIENT IS A SMOKER.

  Patient problems: Failure of Implant; Pain

  MAUDE report 6173354 ↗