Implantium FX4808MLCRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI D755FX4808MLC0), received between May 22, 2017 and Sep 27, 2022 — classified as 10 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2022Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE 3 MONTHS AFTER IMPLANT PLACEMENT SURGERY. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. THE DOCTOR REPORTED NO SIGNIFICANT FINDINGS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 15491505 ↗
• InjurySep 14, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE APPROXIMATELY 3 MONTHS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. DURING THE IMPLANT REMOVAL SURGERY LOCAL INFECTION WAS OBSERVED. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Unspecified Infection

  MAUDE report 12471889 ↗
• InjuryNov 9, 2020Use of Device Problem; Failure to Osseointegrate; Osseointegration Problem; Use of Device Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DOCTOR REPORTED THAT IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, APPROXIMATELY 2 MONTHS FROM IMPLANT PLACEMENT DATE. ORAL HYGIENE AROUND THE IMPLANT SITE WAS MODERATE. BONE QUALITY AT SURGICAL SITE WAS TYPE 1. DURING THE SURGERY, NO SIGNIFICANT FINDING WAS OBSERVED. PATIENT HAS SINCE RECOVERED.

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

  MAUDE report 10813848 ↗
• InjurySep 18, 2020Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE 1 YEAR AND 9 MONTHS AFTER PLACEMENT SURGERY. BONE QUALITY WAS TYPE II AND ORAL HYGIENE AT THE SITE OF THE IMPLANT WAS GOOD. DURING THE SURGERY, NO SIGNIFICANT FINDINGS WERE OBSERVED. THE PATIENT IS SCHEDULED TO PLACE ANOTHER IMPLANT AT THE SITE IN THE FUTURE.

  Patient problems: Inadequate Osseointegration; Patient Problem/Medical Problem

  MAUDE report 10554069 ↗
• InjuryDec 9, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX4808MLC WAS REMOVED ON (B)(6) 2019 DUE TO FAILURE TO OSSEOINTEGRATE 4 MONTHS AND 26 DAYS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE DOCTOR NOTED PAIN DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 9440924 ↗
• InjuryJul 29, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX4808MLC WAS REMOVED ON (B)(6) 2019 DUE TO FAILURE TO OSSEOINTEGRATE 14 DAYS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8838977 ↗
• InjuryApr 16, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT (B)(4) WAS REMOVED ON (B)(6) 2019 DUE TO FAILURE TO OSSEOINTEGRATE AROUND 4 MONTHS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF DIABETES. THE DOCTOR NOTED LOCAL INFECTION DURING THE SURGERY. THE PATIENT REQUIRED BONE AUGMENTATION FOR THE OPERATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 8520589 ↗
• InjuryApr 8, 2019Use of Device Problem; Use of Device Problem

  THE DENTAL IMPLANT FX4808MLC WAS REMOVED ON (B)(6) 2019 DUE TO THE INTERNAL HEX BEING COMPROMISED. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT REQUIRED BONE GRAFTING FOR THE SURGERY. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Failure of Implant

  MAUDE report 8494035 ↗
• InjuryJul 6, 2017Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT, FX4808NLC WAS REMOVED ON (B)(6) 2017 DUE TO LOSS OF OSSEOINTEGRATION 5 YEARS AND 4 MONTHS AFTER IMPLANTATION. THE DOCTOR INDICATED THAT THE BONE RESORPTION CAUSED THE IMPLANT REMOVAL. THE PATIENT HAS MEDICAL HISTORY OF BRUXISM. THE PATIENT NEED ANOTHER SURGICAL INTERVENTION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 6689981 ↗
• InjuryMay 22, 2017Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DNTAL IMPLANT FX4808MLC WAS REMOVED ON (B)(6) 2017 DUE TO LOSS OF OSSEOINTEGRATION 1 YEAR AND 1 MONTH AFTER IMPLANTATION. THE DOCTOR INDICATED THAT THE BONE RESORPTION CAUSED THE IMPLANT REMOVAL. THE PAITENT HAS MEDICAL HISTORY OF BRUXISM. THE PATIENT HAS BEEN RECOVERED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 6583499 ↗

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