miniMark Dental Implant System 11321520Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00614950003556), received between Sep 7, 2023 and Sep 7, 2023 — 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.

• InjurySep 7, 2023Failure to Osseointegrate; Failure to Osseointegrate

  SWELLING AND IMPLANT MOBILITY.

  Patient problems: Failure of Implant

  MAUDE report 17704799 ↗

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.