SuperLine FX3608SWCRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI D755FX3608SWC0), received between Aug 14, 2017 and Sep 16, 2022 — classified as 23 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (18 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. 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2022Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION AND IMPLANT FRACTURE, 2 YEARS AND 9 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. NO SIGNIFICANT FINDING WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 15442818 ↗
• InjuryJan 5, 2022Loss of Osseointegration; Loss of Osseointegration

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATE APPROXIMATELY 5 YEARS, 9 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, 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 13162875 ↗
• InjuryOct 13, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE APPROXIMATELY 3 MONTHS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. BONE RESORPTION AROUND THE IMPLANT PLACEMENT AREA WAS REPORTED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT REQUIRES ANOTHER SURGICAL INTERVENTION.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 12628024 ↗
• InjuryAug 25, 2021Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 12367219 ↗
• InjuryFeb 15, 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 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, PERIODONTAL DISEASE WAS OBSERVED. PATIENT HAS SINCE RECOVERED.

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

  MAUDE report 11330554 ↗
• InjuryNov 9, 2020Use 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 GOOD. BONE QUALITY AT SURGICAL SITE WAS TYPE 1. DURING THE SURGERY, PERIODONTAL DISEASE WAS OBSERVED. PATIENT WILL LATER REQUIRE ANOTHER SURGICAL INTERVENTION.

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

  MAUDE report 10814325 ↗
• InjuryNov 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 OSSEOINTEGRATION FAILURE, APPROXIMATELY 2 MONTHS FROM IMPLANT PLACEMENT DATE. ORAL HYGIENE AROUND THE IMPLANT SITE WAS REPORTED TO BE BOTH MODERATE AND POOR. DURING THE SURGERY, IT WAS REPORTED THAT PATIENT EXPERIENCED NUMBNESS OR AN ABNORMAL SENSATION AROUND IMPLANT PLACEMENT. PATIENT HAS SINCE RECOVERED.

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

  MAUDE report 10813835 ↗
• InjuryNov 4, 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 OSSEOINTEGRATION FAILURE, APPROXIMATELY 2 MONTHS FROM IMPLANT PLACEMENT DATE. BONE TYPE OBSERVED IN THE AREA WAS TYPE 3. DURING THE SURGERY, NO FINDINGS WERE REPORTED. PATIENT HAS SINCE RECOVERED.

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

  MAUDE report 10789471 ↗
• InjuryNov 4, 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 OSSEOINTEGRATION FAILURE, APPROXIMATELY 2 MONTHS FROM IMPLANT PLACEMENT DATE. BONE TYPE OBSERVED IN THE AREA WAS TYPE 3. DURING THE SURGERY, NO FINDINGS WERE REPORTED. PATIENT HAS SINCE RECOVERED.

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

  MAUDE report 10789470 ↗
• InjuryNov 4, 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 OSSEOINTEGRATION FAILURE, APPROXIMATELY 7 MONTHS FROM IMPLANT PLACEMENT. 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 HAS SINCE RECOVERED.

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

  MAUDE report 10789467 ↗
• InjuryAug 11, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX3608SWC WAS REMOVED ON (B)(6) 2020 DUE TO FAILURE TO OSSEOINTEGRATE 11 MONTHS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE DOCTOR NOTED PERIODONTAL DISEASE AND BONE RESORPTION DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10393888 ↗
• InjuryFeb 24, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX3608SWC WAS REMOVED ON (B)(6) 2019 DUE TO FAILURE TO OSSEOINTEGRATE 6 MONTHS AND 6 DAYS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF TOBACCO USE AND DIABETES. THE DOCTOR NOTED PERIODONTAL DISEASE AND BONE RESORPTION DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9745472 ↗
• InjuryDec 9, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX3608SWC WAS REMOVED ON (B)(6) 2019 DUE TO FAILURE TO OSSEOINTEGRATE 1 MONTH AND 15 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 9440897 ↗
• InjuryOct 23, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX3608SWC WAS REMOVED ON (B)(6) 2019 DUE TO FAILURE TO OSSEOINTEGRATE 5 MONTHS AND 21 DAYS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF DIABETES. THE DOCTOR NOTED PERIODONTAL DISEASE AND BONE RESORPTION DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9227067 ↗
• InjuryAug 12, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX3608SWC WAS REMOVED ON (B)(6) 2019 DUE TO FAILURE TO OSSEOINTEGRATE 1 MONTH AND 2 DAYS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF TOBACCO USE AND DIABETES. THE DOCTOR NOTED LOCAL INFECTION DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 8886023 ↗
• InjuryOct 2, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX3608SWC WAS REMOVED ON (B)(6) 2018 DUE TO FAILURE TO OSSEOINTEGRATE 3 MONTHS AND 24 DAYS AFTER IMPLANTATION. THE DOCTOR NOTED BONE RESORPTION DURING EXPLANTATION. THE PATIENT HAS MEDICAL HISTORY OF DIABETES AND HYPERTENSION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7928459 ↗
• InjurySep 11, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX3608SWC WAS REMOVED ON (B)(6) 2018 DUE TO FAILURE TO OSSEOINTEGRATE 2 MONTHS AND 11 DAYS AFTER IMPLANTATION. THE DOCTOR NOTED PERIODONTAL DISEASE AND LOCAL INFECTION DURING EXPLANTATION. THE PATIENT HAS HISTORY OF DIABETES AND IS A TOBACCO USER. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 7867093 ↗
• InjurySep 11, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX3608SWC WAS REMOVED ON (B)(6) 2018 DUE TO FAILURE TO OSSEOINTEGRATE 23 DAYS 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 7867085 ↗
• InjurySep 11, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX3608SWC WAS REMOVED ON (B)(6) 2018 DUE TO FAILURE TO OSSEOINTEGRATE 6 MONTHS AND 1 DAY AFTER IMPLANTATION. THE DOCTOR NOTED PERIODONTAL DISEASE DURING EXPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7867068 ↗
• InjuryMay 31, 2018Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX3608SWC WAS REMOVED ON (B)(6) 2018 DUE TO LOSS OF OSEOINTEGRATION 4 YEARS AND 4 MONTHS AFTER IMPLANTATION. THE DOCTOR NOTED LOCAL INFECTION, PERI-IMPLANTITIS, AND PAIN DURING SURGERY. THE PATIENT HAS MEDICAL HISTORY OF HYPERTENSION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration; Pain; Unspecified Infection

  MAUDE report 7558861 ↗
• InjuryFeb 16, 2018Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX3608SWC WAS REMOVED ON (B)(6) 2017 DUE TO LOSS OF OSSEOINTEGRATION 1 YEAR AND 4 MONTHS AFTER IMPLANTATION. THE DOCTOR NOTED PERIODONTAL DISEASE DURING THE SURGERY. THE PATIENT HAS MEDICAL HISTORY OF DIABETES. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7277589 ↗
• InjuryJan 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DENTAL IMPLANT FX3608SWC WAS REMOVED ON (B)(6) 2017 DUE TO INSUFFICIENT PRIMARY STABILITY ON THE DATE OF IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Failure of Implant

  MAUDE report 7208325 ↗
• InjuryAug 14, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX3608SWC WAS REMOVED ON (B)(6) 2017 DUE TO FAILURE TO OSSEOINTEGRATE 5 MONTHS AFTER IMPLANTATION. THE DOCTOR INDICATED THAT INFECTION CAUSED THE IMPLANT REMOVAL. THE PATIENT HAS HISTORY OF HYPERTENSION AND HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 6793242 ↗