SuperLine FX6010SWCRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI D755FX6010SWC0), received between Jun 16, 2016 and May 9, 2025 — classified as 24 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (16 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.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2025Loss of Osseointegration; Loss of Osseointegration

  THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY 6 YEARS AND 10 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS POOR. PERI-IMPLANTITIS WAS 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

  MAUDE report 21996522 ↗
• InjuryJun 30, 2023Loss of Osseointegration; Loss of Osseointegration

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION, 7 YEARS AND 8 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE IV, 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 17243595 ↗
• InjuryMay 6, 2022Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN ONE YEAR, LESS THAN ONE MONTH AFTER IMPLANT PLACEMENT SURGERY. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. LOCAL INFECTION WAS REPORTED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.

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

  MAUDE report 14309395 ↗
• InjuryDec 13, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO FAILURE TO OSSEOINTEGRATE APPROXIMATELY 3 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. THE DOCTOR REPORTED NO SIGNIFICANT ABNORMAL SENSATION AROUND THE IMPLANT DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 12990451 ↗
• InjuryNov 24, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO INSUFFICIENT PRIMARY STABILITY APPROXIMATELY 2 MONTHS - 1 WEEK AFTER IMPLANT PLACEMENT. HOWEVER THIS CASE WAS ALSO ASSESSED IN THE ASPECT OF OSSEOINTEGRATION FAILURE AS THE IMPLANT WAS EXPLANTED AROUND 2 MONTHS AFTER THE IMPLANT SURGERY. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. THE DOCTOR REPORTED LOCAL INFECTION WAS OBSERVED DURING THE IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.

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

  MAUDE report 12869359 ↗
• InjuryNov 11, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO FAILURE TO OSSEOINTEGRATION 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 PAIN WAS OBSERVED DURING THE IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Pain

  MAUDE report 12801314 ↗
• InjurySep 15, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO INSUFFICIENT PRIMARY STABILITY, HOWEVER, WAS ALSO ASSESSED IN THE ASPECT OF OSSEOINTEGRATION FAILURE AS THE IMPLANT WAS EXPLANTED APPROXIMATELY 3 MONTHS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 12477940 ↗
• InjuryOct 26, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DOCTOR REPORTED THAT IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE APPROXIMATELY A MONTH SINCE THE DATE OF SURGERY. BONE TYPE OBSERVED IN THE AREA WAS TYPE 2, AND ORAL HYGIENE AROUND THE SITE OF SURGERY WAS MODERATE. DURING THE SURGERY, PERI-IMPLANTITIS WAS OBSERVED.

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

  MAUDE report 10738273 ↗
• InjuryJul 27, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX6010SWC WAS REMOVED ON (B)(6) 2020 DUE TO FAILURE TO OSSEOINTEGRATE 5 MONTHS AND 2 DAYS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE DOCTOR NOTED LOCAL INFECTION AND PERIODONTAL DISEASE DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 10329909 ↗
• InjuryApr 28, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX6010SWC WAS REMOVED ON (B)(6) 2020 DUE TO OSSEOINTEGRATION FAILURE AROUND 1 MONTH AND 24 DAYS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF DIABETES. THE DOCTOR NOTED PERIODONTAL DISEASE DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10005913 ↗
• InjurySep 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DENTAL IMPLANT FX6010SWC WAS REMOVED ON (B)(6) 2019 DUE TO A BROKEN ABUTMENT SCREW GETTING STUCK INSIDE THE IMPLANT. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Failure of Implant

  MAUDE report 9107658 ↗
• InjuryFeb 21, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX6010SWC WAS REMOVED ON (B)(6) 2019 DUE TO FAILURE TO OSSEOINTEGRATE 4 MONTHS AND 5 DAYS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE DOCTOR NOTED BONE RESORPTION DURING THE SURGERY. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8358537 ↗
• InjuryFeb 21, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX6010SWC WAS REMOVED ON (B)(6) 2018 DUE TO LOSS OF OSSEOINTEGRATION 3 YEARS AND 2 MONTHS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF TOBACCO USE. THE DOCTOR NOTED PERI-IMPLANTITIS DURING THE SURGERY. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8358474 ↗
• InjuryJan 24, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX6010SWC WAS REMOVED ON (B)(6) 2018 DUE TO LOSS OF OSSEOINTEGRATION AROUND 2 YEARS AND 6 MONTHS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF DIABETES AND IS A TOBACCO USER. THE DOCTOR NOTED PERIODONTAL DISEASE AND BONE RESORPTION DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8274792 ↗
• InjurySep 11, 2018Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX6010SWC WAS REMOVED ON (B)(6) 2018 DUE TO LOSS OF OSSEOINTEGRATION 1 YEAR AFTER IMPLANTATION. THE DOCTOR NOTED BONE RESORPTION DURING EXPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7867123 ↗
• InjuryAug 14, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX6010SWC WAS REMOVED ON (B)(6) 2018 DUE TO FAILURE TO OSSEOINTEGRATE 5 MONTHS AND 11 DAYS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7781922 ↗
• InjuryApr 2, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX6010SWC WAS REMOVED ON (B)(6) 2017 DUE TO FAILURE TO OSSEOINTEGRATE 1 MONTH AND 13 DAYS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT REQUIRED ANOTHER SURGICAL INTERVENTION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7390883 ↗
• InjuryMar 16, 2018Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX6010SWC WAS REMOVED ON (B)(6) 2018 DUE TO LOSS OF OSSEOINTEGRATION 4 YEARS AND 5 MONTHS AFTER IMPLANTATION. THE DOCTOR NOTED PERIODONTAL DISEASE DURING SURGERY. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7346219 ↗
• InjuryMar 12, 2018Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX6010SWC WAS REMOVED ON (B)(6) 2017 DUE TO LOSS OF OSSEOINTEGRATION 1 YEAR AND 3 MONTHS AFTER IMPLANTATION. THE DOCTOR NOTED PERI-IMPLANTITIS DURING SURGERY. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT REQUIRED ANOTHER SURGICAL INTERVENTION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7331351 ↗
• InjuryOct 25, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX6010SWC FELL OUT OF THE SITE ON (B)(6) 2017 DUE TO FAILURE TO OSSEOINTEGRATE APPROXIMATELY 3 MONTHS AFTER IMPLANTATION. THE PATIENT HAD NO SIGNIFICANT MEDICAL HISTORY AND WILL REQUIRE ANOTHER SURGICAL INTERVENTION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 6978486 ↗
• InjuryOct 19, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX6010SWC WAS REMOVED ON (B)(6) 2017 DUE TO FAILURE TO OSSEOINTEGRATE 3 MONTHS AND 2 WEEKS AFTER IMPLANTATION. THE DOCTOR INDICATED THAT OSTEONECROSIS AND CANCER LEAD TO THE IMPLANT REMOVAL. THE PATIENT HAD HISTORY OF CANCER AND HAS BEEN RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 6962301 ↗
• InjuryOct 10, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT (B)(4) WAS REMOVED ON (B)(6) 2017 DUE TO FAILURE TO OSSEOINTEGRATE ONE MONTH AFTER IMPLANTATION. THE DOCTOR INDICATED THAT LOCAL INFECTION AT THE SITE OF THE IMPLANT CAUSED THE IMPLANT REMOVAL. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY AND HAS BEEN RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 6936458 ↗
• InjurySep 29, 2017Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX6010SWC WAS REMOVED ON (B)(6) 2017 DUE TO LOSS OF OSSEOINTEGRATION 1 YEAR AND 11 MONTHS AFTER IMPLANTATION. THE DOCTOR INDICATED THAT BONE RESORPTION AND PERI IMPLANTITIS MAY HAVE CAUSED THE IMPLANT REMOVAL. THE PATIENT HAS HISTORY OF DIABETES AND HAS BEEN RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 6905777 ↗
• InjuryJun 16, 2016Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT, FX6010SWC IN TOOTH LOCATION #11 WAS REMOVED ON (B)(6) 2016 DUE TO LOSS OF OSSEOINTEGRATION AFTER 1 YEAR 8 MONTHS IMPLANTATION. THE DOCTOR INDICATED THAT THE BONE LOSS AND BONE CONDITION OF THE PATIENT CAUSES IMPLANT REMOVAL. THE CONDITION OF THE PATIENT IS RECOVERED WITHOUT COMPLICATIONS AND STABLE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 5730395 ↗