Implantium FX3808MLCRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI D755FX3808MLC0), received between May 11, 2016 and Jan 5, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2022Loss of Osseointegration; Loss of Osseointegration

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATE APPROXIMATELY 2 YEARS, 8 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. THE DOCTOR REPORTED BONE RESORPTION DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT WILL REQUIRE ANOTHER SURGICAL INTERVENTION.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 13162804 ↗
• InjuryJul 19, 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 I, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 12193969 ↗
• InjuryJun 18, 2021Loss of Osseointegration; Loss of Osseointegration

  THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY A YEAR AND 2 MONTHS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE 3, AND ORAL HYGIENE AROUND THE IMPLANT WAS POOR. DURING THE SURGERY, LOCAL INFECTION AND BONE RESORPTION WERE OBSERVED. PATIENT HAS SINCE RECOVERED.

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

  MAUDE report 12026287 ↗
• InjuryNov 12, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX3808MLC WAS REMOVED ON (B)(6) 2019 DUE TO LOSS OF OSSEOINTEGRATION 7 YEARS AND 7 MONTHS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE DOCTOR NOTED PERIODONTAL DISEASE DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9312030 ↗
• InjuryNov 21, 2017Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX3808MLC WAS REMOVED ON (B)(6) 2017 DUE TO LOSS OF OSSEOINTEGRATION 7 YEARS AND 1 MONTH AFTER IMPLANTATION. THE DOCTOR INDICATED THE PERI-IMPLANTITIS MAY HAVE CAUSED THE IMPLANT REMOVAL. THE PATIENT HAS A HISTORY OF HYPERTENSION, DIABETES, AND TOBACCO USE AND HAS BEE RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7050211 ↗
• InjuryJun 28, 2017Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX3808MLC WAS REMOVED FROM PATIENT JAW BONE ON (B)(6)2017 DUE TO LOSS OF OSSEOINTEGRATION AROUND 7 YEARS AND FIVE MONTHS AFTER IMPLANTATION. THE DOCTOR INDICATED THAT THE BONE LOSS CAUSED THE IMPLANT REMOVAL. THE PATIENT HAS NO SIGNIFICANT HEALTH ISSUE. THE ORAL HYGIENE AROUND IMPLANTS FOUND TO BE POOR.

  Patient problems: Inadequate Osseointegration

  MAUDE report 6675747 ↗
• InjuryMay 11, 2016Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT, FX3808MLC IN TOOTH LOCATION #18 WAS REMOVED ON (B)(6) 2016 DUE TO LOSS OF OSSEOINTEGRATION AFTER 4 YEARS 11 MONTHS IMPLANTATION. THE DOCTOR INDICATED THAT THE BONE LOSS WAS CAUSED THAT THE PATIENT'S BITE FORCE WAS OVERLOADED ONTO THE ABUTMENT. THE CONDITION OF THE PATIENT IS STABLE, BUT TREATMENT IS ONGOING FOR RE-IMPLANT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 5647908 ↗

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