miniMark Dental Implant System 10290840 (UDI 00614950003136)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00614950003136), received between Jan 13, 2016 and Jul 25, 2018 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  INFECTION AND SWELLING WERE REPORTED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS UP TO 1 YEAR AFTER PROSTHETIC RESTORATION. BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS TYPE II. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS PERFORMED (PUROS CANCELLOUS). PATIENT IS A SMOKER.

  Patient problems: Failure of Implant; Swelling; Unspecified Infection

  MAUDE report 7717600 ↗
• InjuryMar 29, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  NUMBNESS, FISTULA AND FRACTURE OF THE IMPLANT WERE REPORTED. PRIMARY STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS 1 TO 5 YEARS AFTER PROSTHETIC BREAK. BONE QUALITY AT TIME OF IMPLANT FAILURE TYPE III.

  Patient problems: Failure of Implant; Fistula; Numbness

  MAUDE report 6442426 ↗
• InjuryNov 7, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY AND BONE LOSS WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. NO OSSEOINTEGRATION OF THE IMPLANT MORE THAN A YEAR AFTER FINAL RESTORATION.

  Patient problems: Failure of Implant

  MAUDE report 6083448 ↗
• InjuryOct 26, 2016Osseointegration Problem; Osseointegration Problem

  INADEQUATE BONE QUALITY AND PAIN WAS REPORTED. 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

  MAUDE report 6056789 ↗
• InjuryJun 21, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY WAS REPORTED AT TIME OF IMPLANT FAILURE. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. IT WAS REPORTED FAILURE TO ACHIEVE GOOD PRIMARY STABILITY. INADEQUATE BONE QUALITY.

  Patient problems: Failure of Implant

  MAUDE report 5739556 ↗
• 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 5564146 ↗
• InjuryJan 13, 2016Osseointegration Problem; Osseointegration Problem

  MOBILITY WAS REPORTED AT THE TIME OF IMPLANT FAILURE. NO OSTEOINTEGRATION 3-6 MONTHS AFTER FINAL RESTORATION. IT WAS REPORTED THE PATIENT HAS HYPERTENSION.

  Patient problems: Failure of Implant

  MAUDE report 5364630 ↗