Implantium FX4310MLCRecalls & 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 FX4310MLC is a root-form dental implant placed in the jawbone. The 44 reports mostly describe implants that failed to fuse properly with the bone, so they loosened or were lost and had to be removed, sometimes with infection, bone resorption, and peri-implantitis found during surgery. All 44 reports involve injuries, with no deaths 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 D755FX4310MLC0), received between Feb 10, 2016 and Jun 11, 2026 — classified as 44 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (28 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 Osseointegrate28
- Osseointegration Problem23
- Loss of Osseointegration13
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Inadequate Osseointegration41
- Failure of Implant21
- Unspecified Infection12
- Patient Problem/Medical Problem1
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
InjuryJun 11, 2026Loss of Osseointegration
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY 3 YEARS AND 2 MONTHS AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS TYPE IV. THE ORAL HYGIENE AROUND IMPLANT SITE WAS POOR. LOCAL INFECTION, BONE RESORPTION, AND PERI-IMPLANTITIS WERE OBSERVED DURING THE IMPLANT REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT NEEDS ANOTHER SURGICAL INTERVENTION.
Patient problems: Failure of Implant; Inadequate Osseointegration; Unspecified Infection
MAUDE report 25480283 ↗InjuryMar 25, 2026Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN 1 YEAR, APPROXIMATELY 10 MONTHS AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS TYPE III. 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 24683527 ↗InjuryNov 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, 7 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. LOCAL INFECTION, BONE RESORPTION, AND PERI-IMPLANTITIS WERE FOUND 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; Unspecified Infection
MAUDE report 20729153 ↗InjuryJul 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO INSUFFICIENT PRIMARY STABILITY AND OSSEOINTEGRATION FAILURE, 1 MONTH AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE IV, AND ORAL HYGIENE AROUND THE IMPLANT WAS POOR. NO SIGNIFICANT FINDING 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 19798159 ↗InjuryJan 9, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, 3 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE I, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. NO SIGNIFICANT FINDING WAS 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 18480605 ↗InjuryJul 10, 2023Loss of Osseointegration; Loss of Osseointegration
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION, AROUND 5 YEARS AND 1 MONTH AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. PERI-IMPLANTITIS WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 17294448 ↗InjuryJan 20, 2023Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE 4 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS NOT REPORTED. NO SIGNIFICANT FINDING WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 16218551 ↗InjurySep 8, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO INSUFFICIENT PRIMARY STABILITY 3 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, 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 15384142 ↗InjuryMay 20, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN ONE YEAR, AROUND 5 MONTHS AFTER IMPLANT PLACEMENT SURGERY. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. LOCAL INFECTION AND PERI-IMPLANTITIS WERE REPORTED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Unspecified Infection
MAUDE report 14455352 ↗InjuryMay 19, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN ONE YEAR, AROUND ONE MONTH AFTER IMPLANT PLACEMENT SURGERY. BONE QUALITY AROUND THE AREA WAS TYPE III, 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 14441660 ↗InjuryMay 19, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FALIURE WITHIN ONE YEAR, AROUND 11 MONTHS AFTER IMPLANT PLACEMENT SURGERY. BONE QUALITY AROUND THE AREA WAS TYPE I, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. BONE RESORPTION WAS REPORTED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 14441265 ↗InjuryDec 13, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO FAILURE TO OSSEOINTEGRATE APPROXIMATELY 3.5 MONTHS 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 12990422 ↗InjurySep 15, 2021Loss of Osseointegration; Loss of Osseointegration
THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY 3 YEARS 5 MONTH AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. DURING THE IMPLANT REMOVAL SURGERY, BONE RESORPTION AND PERI-IMPLANTITIS WAS REPORTED. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Unspecified Infection
MAUDE report 12477923 ↗InjuryJun 18, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE APPROXIAMTELY 10 MONTHS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE 3, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. DURING THE SURGERY, BONE RESORPTION WAS OBSERVED. PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 12026283 ↗InjuryJun 18, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE APPROXIMATELY 10 MONTHS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE 3, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. DURING THE SURGERY, BONE RESORPTION WAS OBSERVED. PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 12026281 ↗InjuryJun 18, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE APPROXIMATELY 7 MONTHS AND A HALF 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 WAS OBSERVED. PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 12026277 ↗InjuryMar 20, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE OSSEOINTEGRATION FAILURE APPROXIMATELY 11 MONTHS AFTER 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. PT. HAS RECOVERED SINCE.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 11536697 ↗InjuryMar 20, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE OSSEOINTEGRATION FAILURE APPROXIMATELY 4 MONTHS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE 3, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. DURING THE SURGERY, NO SIGNIFICANT FINDINGS WERE OBSERVED. PATIENT HAS RECOVERED SINCE.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 11536695 ↗InjurySep 11, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE 2 MONTHS AFTER PLACEMENT SURGERY. BONE QUALITY WAS TYPE II AND ORAL HYGIENE AT THE SITE OF THE IMPLANT WAS MODERATE. DURING THE SURGERY, LOCAL INFECTION WAS OBSERVED.
Patient problems: Inadequate Osseointegration; Patient Problem/Medical Problem; Unspecified Infection
MAUDE report 10524129 ↗InjuryJul 14, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
THE DENTAL IMPLANT FX4310MLC WAS REMOVED ON (B)(6) 2020 DUE TO FAILURE TO OSSEOINTEGRATE 2 MONTHS AND 18 DAYS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF HYPERTENSION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.
Patient problems: Inadequate Osseointegration
MAUDE report 10271795 ↗InjuryMay 19, 2020Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem
THE DENTAL IMPLANT FX4310 MLC WAS REMOVED ON (B)(6) 2020 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 10071168 ↗InjuryApr 22, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
THE DENTAL IMPLANT FX4310MLC WAS REMOVED ON (B)(6) 2019 DUE TO FAILURE TO OSSEOINTEGRATE 2 MONTHS AND 12 DAYS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE DOCTOR NOTED LOCAL INFECTION DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 9988386 ↗InjuryMar 4, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
THE DENTAL IMPLANT FX4310MLC WAS REMOVED ON (B)(6) 2020 DUE TO FAILURE TO OSSEOINTEGRATE 7 MONTHS AND 14 DAYS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT REQUIRED BONE AUGMENTATION FOR THE OPERATION. THE DOCTOR NOTED BONE RESORPTION DURING EXPLANTATION. THE PATIENT HAS REQUIRED ANOTHER SURGICAL INTERVENTION TO RECOVER.
Patient problems: Inadequate Osseointegration
MAUDE report 9789388 ↗InjuryAug 23, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
THE DENTAL IMPLANT FX4310MLC WAS REMOVED ON (B)(6) 2019 DUE TO FAILURE TO OSSEOINTEGRATE 2 DAYS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF TOBACCO USE. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.
Patient problems: Inadequate Osseointegration
MAUDE report 8926404 ↗InjuryJul 19, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem
THE DENTAL IMPLANT FX4310MLC WAS REMOVED ON (B)(6) 2019 DUE TO LOSS OF OSSEOINTEGRATION 8 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 8809490 ↗
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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