miniMark Dental Implant System 11321005Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00614950003457), received between Mar 25, 2019 and Mar 25, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).

1 other recall cover devices cleared under the same FDA submission (K093518); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  DOCTOR CHOSE A DIFFERENT SIZE. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE I. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED.

  Patient problems: Failure of Implant

  MAUDE report 8447517 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093518. One submission often covers many models, so check the product and lot details in each record.

• Z-1835-2017 · Feb 22, 2017 · Terminated
  INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage: Non implantable dental abutment.