SuperLine FX4512SWCRecalls & reported problems
Dentium USA · Endosseous dental implant · Class 2 · Implant
Quick summary
This Dentium SuperLine FX4512SWC is a root-form endosseous dental implant used as a tooth replacement anchor in the jawbone. The 43 reports mostly describe the implant failing to bond with the surrounding bone or losing that bond later, so it has to be removed; reports also mention infection, pain, and bone loss around the site. There are 43 injuries and no deaths. 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
- 43
- Deaths reported
- 0
- Injuries reported
- 43
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI D755FX4512SWC0), received between Oct 23, 2017 and Jun 3, 2025 — classified as 43 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (34 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate34
- Osseointegration Problem30
- Loss of Osseointegration8
- Use of Device Problem4
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Inadequate Osseointegration42
- Failure of Implant19
- Unspecified Infection10
- Patient Problem/Medical Problem8
- Pain4
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
InjuryJun 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, 1 MONTH AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. 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 22135155 ↗InjuryDec 31, 2024Loss of Osseointegration; Loss of Osseointegration
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION,8 YEARS AND 9 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. LOCAL INFECTION 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; Unspecified Infection
MAUDE report 21050437 ↗InjuryJul 16, 2024Loss of Osseointegration; Loss of Osseointegration
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION, 1 YEAR AND 4 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. PAIN 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; Pain
MAUDE report 19757256 ↗InjuryNov 1, 2023Loss of Osseointegration; Loss of Osseointegration
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY 2 YEARS AND 8 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. LOCAL INFECTION, PAIN, ABNORMAL SENSATION AROUND IMPLANT PLACEMENT WERE OBSERVED DURING THE IMPLANT REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS NOT USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT WILL NEED ANOTHER SURGICAL INTERVENTION.
Patient problems: Failure of Implant; Inadequate Osseointegration; Pain; Unspecified Infection
MAUDE report 18049051 ↗InjuryJul 5, 2023Loss of Osseointegration; Loss of Osseointegration
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION, 4 YEARS AND 6 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, 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 17259681 ↗InjuryOct 1, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, AROUND TWO MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. BONE RESORPTION WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 15523719 ↗InjurySep 23, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE 2 MONTHS AFTER IMPLANT PLACEMENT SURGERY. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. THE DOCTOR REPORTED BONE RESORPTION AND PAIN WERE OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Pain
MAUDE report 15473147 ↗InjuryDec 13, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATE APPROXIMATELY 1 YEAR - 1 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 AND PAIN DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 12990482 ↗InjuryAug 25, 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 III, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. DURING THE SURGERY, NO SIGNIFICANT FINDING WAS REPORT. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 12368708 ↗InjuryJun 3, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE APPROXIMATELY A MONTH AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE 3, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. DURING THE SURGERY, BONE RESORPTION AND GRANULOMA WERE OBSERVED. PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 11936052 ↗InjuryMay 2, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE APPROXIMATELY THREE 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. PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 11758782 ↗InjuryMar 20, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE OSSEOINTEGRATION FAILURE APPROXIMATELY A MONTH 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 RECOVERED SINCE.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 11536668 ↗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 4 YEARS AND 9 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 AND PERIODONTAL DISEASE WERE OBSERVED. PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Patient Problem/Medical Problem
MAUDE report 11330557 ↗InjuryJan 26, 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 LOSS OF OSSEOINTEGRATION APPROXIMATELY TWO MONTHS AFTER THE INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE 3, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. DURING THE SURGERY, THERE WERE LOCAL INFECTION AND BONE RESORPTION OBSERVED. PATIENT WILL LATER NEED ANOTHER SURGICAL INTERVENTION.
Patient problems: Failure of Implant; Inadequate Osseointegration; Patient Problem/Medical Problem; Unspecified Infection
MAUDE report 11233923 ↗InjuryDec 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 FAILURE OF OSSEOINTEGRATION, APPROXIMATELY 3 MONTHS AFTER THE IMPLANT PLACEMENT DATE. ORAL HYGIENE AROUND THE IMPLANT SITE WAS MODERATE. BONE QUALITY AT SURGICAL SITE WAS TYPE 3. DURING THE SURGERY, NO SIGNIFICANT FINDINGS WERE OBSERVED. PATIENT HAS RECOVERED SINCE.
Patient problems: Failure of Implant; Inadequate Osseointegration; Patient Problem/Medical Problem
MAUDE report 10978445 ↗InjuryDec 6, 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 FAILURE OF OSSEOINTEGRATION, APPROXIMATELY 8 MONTHS AFTER THE IMPLANT PLACEMENT DATE. ORAL HYGIENE AROUND THE IMPLANT SITE WAS GOOD. BONE QUALITY AT SURGICAL SITE WAS TYPE 1. DURING THE SURGERY, NO SIGNIFICANT FINDINGS WERE OBSERVED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Patient Problem/Medical Problem
MAUDE report 10955914 ↗InjuryOct 26, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
THE DOCTOR REPORTED THAT IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE APPROXIMATELY 2 MONTHS SINCE THE DATE OF SURGERY. BONE TYPE OBSERVED IN THE AREA WAS TYPE 2, AND ORAL HYGIENE AROUND THE SITE OF SURGERY WAS GOOD. DURING THE SURGERY, NO FINDINGS WERE REPORTED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Patient Problem/Medical Problem
MAUDE report 10738269 ↗InjurySep 25, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE LESS THAN A MONTH AFTER PLACEMENT SURGERY. ORAL HYGIENE AT THE SITE OF THE IMPLANT WAS GOOD. DURING THE SURGERY, NO SIGNIFICANT FINDINGS WERE OBSERVED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Patient Problem/Medical Problem
MAUDE report 10587731 ↗InjurySep 6, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE LESS THAN A MONTH AFTER PLACEMENT SURGERY. BONE QUALITY WAS TYPE III AND ORAL HYGIENE AT THE SITE OF THE IMPLANT WAS MODERATE. DURING THE SURGERY, LOCAL INFECTION, PERI-IMPLANTITIS, AND BONE RESORPTION WERE OBSERVED. THE PATIENT WILL LATER NEED ANOTHER SURGICAL INTERVENTION TO COMPLETE TX.
Patient problems: Inadequate Osseointegration; Patient Problem/Medical Problem; Unspecified Infection
MAUDE report 10498284 ↗InjurySep 6, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE LESS THAN A MONTH AFTER PLACEMENT SURGERY. BONE QUALITY WAS TYPE III AND ORAL HYGIENE AT THE SITE OF THE IMPLANT WAS MODERATE. DURING THE SURGERY, LOCAL INFECTION, PERI-IMPLANTITIS, AND BONE RESORPTION WERE OBSERVED. THE PATIENT WILL LATER NEED ANOTHER SURGICAL INTERVENTION TO COMPLETE TX.
Patient problems: Inadequate Osseointegration; Patient Problem/Medical Problem; Unspecified Infection
MAUDE report 10498280 ↗InjuryAug 11, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
THE DENTAL IMPLANT FX4512SWC WAS REMOVED ON (B)(6) 2020 DUE TO FAILURE TO OSSEOINTEGRATE 19 DAYS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF DIABETES. THE PATIENT REQUIRED BONE AUGMENTATION FOR THE OPERATION. THE DOCTOR NOTED BONE RESORPTION DURING EXPLANTATION. THE PATIENT REQUIRED ANOTHER SURGICAL INTERVENTION TO RECOVER.
Patient problems: Inadequate Osseointegration
MAUDE report 10393854 ↗InjuryJul 31, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
THE DENTAL IMPLANT FX4512SWC WAS REMOVED ON (B)(6) 2020 DUE TO OSSEOINTEGRATION FAILURE AROUND 1 MONTH AND 18 DAYS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT REQUIRED BONE AUGMENTATION FOR THE OPERATION. THE DOCTOR NOTED PERI-IMPLANTITIS DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.
Patient problems: Inadequate Osseointegration
MAUDE report 10353201 ↗InjuryJul 31, 2020Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem
THE DENTAL IMPLANT FX4512SWC WAS REMOVED ON (B)(6) 2020 DUE TO LOSS OF OSSEOINTEGRATION 4 YEARS AND 3 MONTHS 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 RECOVERED WITHOUT COMPLICATIONS.
Patient problems: Inadequate Osseointegration
MAUDE report 10353151 ↗InjuryMar 19, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
THE DENTAL IMPLANT FX4512SWC WAS REMOVED ON (B)(6) 2020 DUE TO FAILURE TO OSSEOINTEGRATE 6 MONTHS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT REQUIRED BONE AUGMENTATION FOR THE OPERATION. THE DOCTOR NOTED PERIODONTAL DISEASE DURING EXPLANTATION. THE PATIENT REQUIRED ANOTHER SURGICAL INTERVENTION TO RECOVER.
Patient problems: Inadequate Osseointegration
MAUDE report 9857617 ↗InjuryMar 19, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
THE DENTAL IMPLANT FX4512SWC WAS REMOVED ON (B)(6) 2020 DUE TO FAILURE TO OSSEOINTEGRATE 6 MONTHS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT REQUIRED BONE AUGMENTATION FOR THE OPERATION. THE DOCTOR NOTED PERIODONTAL DISEASE DURING EXPLANTATION. THE PATIENT REQUIRED ANOTHER SURGICAL INTERVENTION TO RECOVER.
Patient problems: Inadequate Osseointegration
MAUDE report 9857598 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.