Implantium FX4810MLCRecalls & reported problems
Dentium USA · Endosseous dental implant · Class 2 · Implant
All models of Implantium (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Dentium Implantium FX4810MLC is a root-form dental implant placed in the jawbone. Most of the 44 reports describe the implant failing to fuse with the surrounding bone or later losing that bond, so it had to be removed; some also mention infection around the site, pain, and one report of a fractured abutment screw. All 44 reports involved injuries and no deaths were reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 44
- Deaths reported
- 0
- Injuries reported
- 44
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI D755FX4810MLC0), received between Jun 28, 2017 and Mar 6, 2026 — classified as 44 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (23 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.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate23
- Osseointegration Problem23
- Loss of Osseointegration15
- Use of Device Problem6
- Adverse Event Without Identified Device or Use Problem5
Patient problems
- Inadequate Osseointegration38
- Failure of Implant26
- Unspecified Infection13
- Pain7
- Patient Problem/Medical Problem6
- No Code Available1
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
InjuryMar 6, 2026Loss of Osseointegration
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION AFTER 1 YEAR, APPROXIMATELY 6 YEARS AND 8 MONTHS AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS TYPE II. THE ORAL HYGIENE AROUND IMPLANT SITE WAS MODERATE. BONE RESORPTION WAS OBSERVED DURING THE REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 24533742 ↗InjuryJun 3, 2025Loss of Osseointegration; Loss of Osseointegration
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION, 1 YEAR AND 5 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS POOR. NO SIGNIFICANT FINDINGS WERE OBSERVED DURING THE IMPLANT REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS NOT USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 22135163 ↗InjuryJun 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, 7 DAYS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. ABNORMAL SENSATION AROUND IMPLANT PLACEMENT WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 22135129 ↗InjuryJan 22, 2025Loss of Osseointegration; Loss of Osseointegration
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION AFTER 1 YEAR, APPROXIMATELY 15 YEARS AND 8 MONTHS AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS TYPE II. ORAL HYGIENE AROUND IMPLANT SITE WAS MODERATE. PERI-IMPLANTITIS AND PAIN WERE FOUND DURING THE REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Pain
MAUDE report 21211008 ↗InjuryOct 13, 2023Loss of Osseointegration; Loss of Osseointegration
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION, AROUND 1 YEAR AND 9 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. PAIN WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Pain
MAUDE report 17933723 ↗InjuryNov 21, 2022Loss of Osseointegration; Loss of Osseointegration
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY 1 YEAR AND 1 MONTH AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. THE DOCTOR REPORTED NO SIGNIFICANT FINDINGS DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 15839222 ↗InjurySep 23, 2022Loss of Osseointegration; Loss of Osseointegration
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO FAILURE TO OSSEOINTEGRATE APPROXIMATELY 6 YEARS AND 5 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE I, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. THE DOCTOR REPORTED NO SIGNIFICANT FINDINGS DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 15473340 ↗InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO ABUTMENT SCREW FRACTURE WITHIN 6 YEARS AND 8 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY WAS TYPE I. ORAL HYGIENE AROUND IMPLANT SITE WAS GOOD. NO SIGNIFICANT FINDING WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT WILL NEED ANOTHER SURGICAL INTERVENTION.
Patient problems: Failure of Implant
MAUDE report 15060260 ↗InjuryMay 20, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN ONE YEAR, AROUND 9 MONTHS AFTER IMPLANT PLACEMENT SURGERY. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. BONE RESORPTION WAS REPORTED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 14455334 ↗InjuryOct 13, 2021Loss of Osseointegration; Loss of Osseointegration
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY 3 YEARS - 11 MONTHS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. BONE RESORPTION AND LOCAL INFECTION AROUND THE IMPLANT PLACEMENT AREA WAS REPORTED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Unspecified Infection
MAUDE report 12628040 ↗InjurySep 17, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE APPROXIMATELY 1 MONTH AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. ABNORMAL SENSATION AROUND THE IMPLANT PLACEMENT AREA WAS REPORTED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 12492906 ↗InjuryJul 19, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE APPROXIMATELY 1 MONTH AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. DURING THE SURGERY PAIN WAS REPORTED. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Pain
MAUDE report 12194018 ↗InjuryMay 23, 2021Loss of Osseointegration; Loss of Osseointegration
THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY TWO YEARS AND 4 MONTHS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE 2, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. DURING THE SURGERY, NO SIGNIFICANT FINDINGS WERE OBSERVED. PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 11868763 ↗InjuryMay 2, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE APPROXIMATELY 6 MONTHS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE 2, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. DURING THE SURGERY, PAIN WAS OBSERVED. PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Pain
MAUDE report 11758784 ↗InjuryMar 20, 2021Loss of Osseointegration; Loss of Osseointegration
THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE LOSS OF OSSEOINTEGRATION APPROXIMATELY 1 YEAR AND 5 MONTHS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE 2, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. DURING THE SURGERY, NO SIGNIFICANT FINDINGS WERE OBSERVED. PT. HAS RECOVERED SINCE.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 11536698 ↗InjuryMar 20, 2021Loss of Osseointegration; Loss of Osseointegration
THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE LOSS OF OSSEOINTEGRATION APPROXIMATELY 2 YEARS AND 5 MONTHS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE 2, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. DURING THE SURGERY, BONE RESORPTION, PERI-IMPLANTITIS, AND PAIN WERE OBSERVED. PT. HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Pain
MAUDE report 11536664 ↗InjuryFeb 15, 2021Use of Device Problem; Loss of Osseointegration; Osseointegration Problem; Use of Device Problem; Loss of Osseointegration; Osseointegration Problem
THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY 10 YEARS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE 2, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. DURING THE SURGERY, LOCAL INFECTION AND BONE RESORPTION WERE OBSERVED. PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Patient Problem/Medical Problem; Unspecified Infection
MAUDE report 11330547 ↗InjuryFeb 15, 2021Use of Device Problem; Loss of Osseointegration; Osseointegration Problem; Use of Device Problem; Loss of Osseointegration; Osseointegration Problem
THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY 10 YEARS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE 2, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. DURING THE SURGERY, LOCAL INFECTION AND BONE RESORPTION WERE OBSERVED. PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Patient Problem/Medical Problem; Unspecified Infection
MAUDE report 11330546 ↗InjuryJan 3, 2021Use 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 FAILURE OF OSSEOINTEGRATION, APPROXIMATELY 40 DAYS AFTER THE IMPLANT PLACEMENT DATE. ORAL HYGIENE AROUND THE IMPLANT SITE WAS MODERATE. BONE QUALITY AT SURGICAL SITE WAS TYPE 2. DURING THE SURGERY, LOCAL INFECTION WAS OBSERVED. PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Patient Problem/Medical Problem; Unspecified Infection
MAUDE report 11106143 ↗InjuryJan 3, 2021Use of Device Problem; Loss of Osseointegration; Osseointegration Problem; Use of Device Problem; Loss of Osseointegration; Osseointegration Problem
THE DOCTOR REPORTED THAT IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION, APPROXIMATELY 2 YEARS AFTER THE IMPLANT PLACEMENT DATE. ORAL HYGIENE AROUND THE IMPLANT SITE WAS MODERATE. BONE QUALITY AT SURGICAL SITE WAS TYPE 2. DURING THE SURGERY, LOCAL INFECTION AND BONE RESORPTION WERE OBSERVED. PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Patient Problem/Medical Problem; Unspecified Infection
MAUDE report 11106142 ↗InjuryJan 3, 2021Use 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 FAILURE OF OSSEOINTEGRATION, APPROXIMATELY 4 MONTHS AFTER THE IMPLANT PLACEMENT DATE. ORAL HYGIENE AROUND THE IMPLANT SITE WAS GOOD. BONE QUALITY AT SURGICAL SITE WAS TYPE 2. DURING THE SURGERY, LOCAL INFECTION WAS OBSERVED. PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Patient Problem/Medical Problem; Unspecified Infection
MAUDE report 11106141 ↗InjurySep 25, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO FAILURE TO OSSEOINTEGRATE LESS THAN A MONTH SINCE THE DATE OF SURGERY. ORAL HYGIENE AT THE SITE OF THE IMPLANT WAS MODERATE. BONE QUALITY AT SITE OF SURGERY WAS TYPE 2. DURING THE SURGERY, LOCAL INFECTION AND PAIN WERE OBSERVED. PATIENT HAS RECOVERED SINCE.
Patient problems: Failure of Implant; Inadequate Osseointegration; Pain; Patient Problem/Medical Problem; Unspecified Infection
MAUDE report 10587744 ↗InjuryAug 11, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
THE DENTAL IMPLANT FX4810MLC WAS REMOVED ON (B)(6) 2020 DUE TO FAILURE TO OSSEOINTEGRATE 4 MONTHS AND 7 DAYS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT REQUIRED BONE AUGMENTATION FOR THE OPERATION. THE DOCTOR NOTED LOCAL INFECTION AND PAIN DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.
Patient problems: Inadequate Osseointegration; Pain; Unspecified Infection
MAUDE report 10393798 ↗InjuryJul 14, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
THE DENTAL IMPLANT FX4810MLC WAS REMOVED ON (B)(6) 2020 DUE TO FAILURE TO OSSEOINTEGRATE 4 MONTHS AND 4 DAYS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT REQUIRED BONE AUGMENTATION FOR THE OPERATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.
Patient problems: Inadequate Osseointegration
MAUDE report 10271773 ↗InjuryApr 22, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
THE DENTAL IMPLANT FX4810MLC WAS REMOVED ON (B)(6) 2019 DUE TO FAILURE TO OSSEOINTEGRATE 3 MONTHS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.
Patient problems: Inadequate Osseointegration
MAUDE report 9988429 ↗
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 · TerminatedBiomedicare Implantium Fixtures, Model numbers : FX3408, FX3410, FX3412, FX3414, FX3808, FX3810, FX3812, FX3814, FX4308, FX4310, FX4312, FX4314, FX4808, FX4810, FX4812, FX4814, FX4
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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