Implantium FX3410MLCRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI D755FX3410MLC0), received between Jun 19, 2018 and Jun 6, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2023Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE 2 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. NO SIGNIFICANT FINDING WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 17073364 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO IMPLANT FRACTURE, APPROXIMATELY 3 YEARS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. THE DOCTOR REPORTED THAT PERI-IMPLANTITIS WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT WILL NEED ANOTHER SURGICAL INTERVENTION.

  Patient problems: Failure of Implant

  MAUDE report 17067117 ↗
• InjuryMar 4, 2022Failure to Osseointegrate; Failure to Osseointegrate

  HOLD AT 3.7 THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO FAILURE OF OSSEOINTEGRATION APPROXIMATELY 17 DAYS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. THE DOCTOR REPORTED THE PATIENT HAD LOCAL INFECTION DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT WILL NEED ANOTHER SURGICAL INTERVENTION.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 13676433 ↗
• InjuryFeb 15, 2021Use of Device Problem; Failure to Osseointegrate; Osseointegration Problem; Use of Device Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE APPROXIMATELY A MONTH AFTER THE INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE 3, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. DURING THE SURGERY, NO SIGNIFICANT FINDINGS WERE OBSERVED. PATIENT HAS SINCE RECOVERED, BUT WILL BE RE-EVALUATED IN 3 MONTHS TO SCHEDULE NEW IMPLANT PLACEMENT.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Patient Problem/Medical Problem

  MAUDE report 11330543 ↗
• InjuryMay 19, 2020Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX3410MLC WAS REMOVED ON (B)(6) 2020 DUE TO LOSS OF OSSEOINTEGRATION 9 YEARS AND 9 MONTHS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF HYPERTENSION. THE DOCTOR NOTED PERIODONTAL DISEASE DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10072922 ↗
• InjuryMay 19, 2020Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX3410MLC WAS REMOVED ON (B)(6) 2020 DUE TO LOSS OF OSSEOINTEGRATION 8 YEARS AND 9 MONTHS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF TOBACCO USE AND DIABETES. THE DOCTOR NOTED BONE RESORPTION DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10072899 ↗
• InjuryMay 19, 2020Use of Device Problem; Loss of Osseointegration; Use of Device Problem; Loss of Osseointegration

  THE DENTAL IMPLANT FX3410MLC WAS REMOVED ON (B)(6) 2020 DUE TO AN IMPLANT FRACTURE 8 YEARS AND 9 MONTHS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF DIABETES AND BRUXISM. THE DOCTOR NOTED LOCAL INFECTION DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Failure of Implant

  MAUDE report 10072885 ↗
• InjuryMay 19, 2020Use of Device Problem; Loss of Osseointegration; Use of Device Problem; Loss of Osseointegration

  THE DENTAL IMPLANT FX3410 MLC WAS REMOVED ON (B)(6) 2020 DUE TO A FRACTURE OF THE IMPLANT. THE PATIENT HAS HISTORY OF DIABETES AND BRUXISM. THE DOCTOR NOTED LOCAL INFECTION DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Failure of Implant

  MAUDE report 10071204 ↗
• InjuryJun 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DENTAL IMPLANT FX3410MLC WAS REMOVED ON (B)(6) 2018 DUE TO THE PATIENT COMPLAINING ABOUT PAIN 1 WEEK AFTER IMPLANTATION. THE DOCTOR NOTED PAIN DURING SURGERY. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT REQUIRED ANOTHER SURGICAL INTERVENTION TO RECOVER.

  Patient problems: Pain

  MAUDE report 7617536 ↗

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