Implantium FX4314MLCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI D755FX4314MLC0), received between Aug 15, 2017 and May 25, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K041368); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 25, 2022Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE APPROXIMATELY THREE MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE I, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. NO SIGNIFICANT FINDINGS WERE OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 14499651 ↗
• InjuryAug 10, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY 4 YEARS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. DURING THE SURGERY BONE RESORPTION AND PERI-IMPLANTITIS WAS REPORTED. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Post Operative Wound Infection

  MAUDE report 12305052 ↗
• InjuryAug 15, 2017Use of Device Problem; Use of Device Problem

  THE DENTAL IMPLANT FX4314MLC WAS REMOVED ON (B)(6) 2017 DUE TO THREAD DAMAGE ON THE IMPLANT ON THE SAME DAY OF IMPLANTATION. THE PATIENT HAS MEDICAL HISTORY OF HYPERTENSION AND HAS BEEN RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: No Code Available

  MAUDE report 6794322 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041368. One submission often covers many models, so check the product and lot details in each record.

• Z-1119-2007 · Jun 29, 2007 · Terminated
  Biomedicare Implantium Fixtures, Model numbers : FX3408, FX3410, FX3412, FX3414, FX3808, FX3810, FX3812, FX3814, FX4308, FX4310, FX4312, FX4314, FX4808, FX4810, FX4812, FX4814, FX4