SuperLine FX6008SWCRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI D755FX6008SWC0), received between Jan 6, 2016 and May 4, 2026 — classified as 21 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (13 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2026Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN 1 YEAR, APPROXIMATELY 1 YEAR AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS TYPE III. THE ORAL HYGIENE AROUND IMPLANT SITE WAS GOOD. THE DOCTOR NOTED OSSEOINTEGRATION FAILURE WAS OBSERVED DURING THE REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT WILL NEED ANOTHER SURGICAL INTERVENTION.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 25074704 ↗
• InjuryAug 19, 2025Loss of Osseointegration; Loss of Osseointegration

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY 3 YEARS AND 1 MONTH AFTER IMPLANT PLACEMENT. HE ALSO MENTIONED THAT THE IMPLANT WAS DEFORMED, AND SCREW WAS BROKEN AS WELL. WHEN DENTIUM STAFF, (B)(6), REACHED OUT FOR CLARIFICATION, AMANDA (SURGICAL ASSISTANT) EXPLAINED THAT THE IMPLANT WAS DIFFICULT TO REMOVE. THE STRENGTH OF FORCEPS CAUSED IMPRESSION ON THE FIXTURE, AND NOT THE FIXTURE ITSELF DEFORMING. THE BONE QUALITY WAS TYPE II. THE ORAL HYGIENE AROUND IMPLANT SITE WAS MODERATE. 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 22845605 ↗
• InjurySep 28, 2023Loss of Osseointegration; Loss of Osseointegration

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION, 4 YEARS AND 3 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. PERI-IMPLANTITIS WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT WILL NEED ANOTHER SURGICAL INTERVENTION.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 17830777 ↗
• InjurySep 19, 2023Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO INFECTION LESS THAN 2 MONTHS AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS TYPE III. THE ORAL HYGIENE AROUND IMPLANT SITE WAS MODERATE. LOCAL INFECTION, BONE RESORPTION AND ENCAPSULATION WERE REPORTED DURING THE IMPLANT REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT WILL NEED ANOTHER SURGICAL INTERVENTION.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 17777694 ↗
• InjuryMay 20, 2022Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN ONE YEAR, APPROXIMATELY 3 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 14459435 ↗
• InjuryOct 28, 2021Loss of Osseointegration; Loss of Osseointegration

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY 1 YEAR - 6 MONTHS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. THE DOCTOR REPORTED A SIGNIFICANT CASE OF PERI-IMPLANTITIS AROUND THE IMPLANT PLACEMENT AREA. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 12716473 ↗
• InjuryMar 20, 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 MODERATE. DURING THE SURGERY, BONE RESORPTION AND PERIODONTAL DISEASE WERE OBSERVED. PATIENT HAS RECOVERED SINCE.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 11536672 ↗
• InjuryDec 6, 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 AND 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, BONE RESORPTION WAS OBSERVED. PATIENT HAS RECOVERED SINCE.

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

  MAUDE report 10955924 ↗
• InjuryAug 11, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX6008SWC WAS REMOVED ON (B)(6) 2020 DUE TO FAILURE TO OSSEOINTEGRATE 6 MONTHS AND 3 DAYS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF TOBACCO USE, DRUG ABUSE, HYPERTENSION, AND DIABETES. THE DOCTOR NOTED PERIODONTAL DISEASE AND BONE RESORPTION DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10393870 ↗
• InjuryApr 22, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX6008SWC WAS REMOVED ON (B)(6) 2020 DUE TO FAILURE TO OSSEOINTEGRATE 4 MONTHS AND 25 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 9988538 ↗
• InjuryNov 12, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX6008SWC WAS REMOVED ON (B)(6) 2019 DUE TO FAILURE TO OSSEOINTEGRATE 4 MONTHS AND 26 DAYS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF HYPERTENSION AND DIABETES. THE DOCTOR NOTED PERIODONTAL DISEASE DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9312109 ↗
• InjuryJul 19, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX6008SWC WAS REMOVED ON (B)(6) 2019 DUE TO FAILURE TO OSSEOINTEGRATE 16 DAYS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF TOBACCO USE, HYPERTENSION, AND DIABETES. THE DOCTOR NOTED LOCAL INFECTION DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 8809450 ↗
• InjuryMay 7, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX6008SWC WAS REMOVED ON (B)(6) 2019 DUE TO FAILURE TO OSSEOINTEGRATE 5 MONTHS AND 10 DAYS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8589153 ↗
• InjuryAug 31, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX6008SWC WAS REMOVED ON (B)(6) 2018 DUE TO FAILURE TO OSSEOINTEGRATE 1 MONTH AFTER IMPLANTATION. THE PATIENT REQUIRED BONE AUGMENTATION FOR THE SURGERY. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7839575 ↗
• InjuryJul 3, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX6008SWC WAS REMOVED ON (B)(6) 2018 DUE TO FAILURE TO OSSEOINTEGRATE 1 MONTH AND 17 DAYS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7660998 ↗
• InjuryNov 21, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX6008SWC WAS REMOVED ON (B)(6) 2017 DUE TO FAILURE TO OSSEOINTEGRATE 21 DAYS AFTER IMPLANTATION. THE DOCTOR INDICATED THAT LOCAL INFECTION MAY HAVE CAUSED THE IMPLANT REMOVAL. THE PATIENT HAS A HISTORY OF DIABETES AND TOBACCO USE AND HAS BEEN RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 7050117 ↗
• InjuryOct 19, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX6008SWC WAS REMOVED ON (B)(6) 2017 5 MONTHS AFTER IMPLANTATION DUE TO FAILURE TO OSSEOINTEGRATE. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY AND MAY NEED ANOTHER SURGICAL INTERVENTION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 6962545 ↗
• InjurySep 8, 2017Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX6008SWC WAS REMOVED ON (B)(6)2017 DUE TO LOSS OF OSSEOINTEGRATION 2 YEARS AND 4 MONTHS AFTER IMPLANTATION. THE DOCTOR INDICATED THAT PERIODONTAL DISEASE CAUSED THE IMPLANT REMOVAL. THE PATIENT HAS HISTORY OF TABACCO USE AND HAS BEEN RECOVERD WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 6852332 ↗
• InjuryMar 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DENTAL IMPLANT, FX6008SWC IN TOOTH LOCATION 31 WAS REMOVED ON (B)(6) 2016 DUE TO ABNORMAL SENSATION 28 DAYS AFTER IMPLANTATION. THE DOCTOR INDICATED THAT THE ABNORMAL SENSATION CAUSED THE IMPLANT REMOVAL. THE PATIENT HAD MEDICAL HISTORY OF DIABETIC. THE PATIENT'S CONDITION BECAME STABLE.

  Patient problems: Numbness

  MAUDE report 6414617 ↗
• InjuryFeb 22, 2016Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PATIENT DEVELOPED A LOSS OF INTEGRATION 2 YEARS 1 MONTH AFTER IMPLANTATION OF THE DENTAL IMPLANT FX6008SWC IN TOOTH LOCATION #14. IMPLANT WAS REMOVED ON (B)(6) 2016 DUE TO LOSS OF INTEGRATION AND PAIN. THE PATIENT IS RECOVERED WITHOUT COMPLICATION AND TREATMENT IS ONGOING.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 5451577 ↗
• InjuryJan 6, 2016Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PATIENT DEVELOPED BONE LOSS AFTER IMPLANTATION OF THE DENTAL IMPLANT FX6008SWC IN TOOTH LOCATION #3. IMPLANT WAS REMOVED ON (B)(6) 2015 AFTER 2 YEARS 4 MONTHS FROM THE IMPLANTATION DUE TO BONE CONDITION, INFECTION AND POOR ORAL HYGIENE. THE PATIENT HAD A MEDICAL HISTORY, DIABETIC. RE-IMPLANTATION WILL BE PERFORMED FOR THE PATIENT.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 5348848 ↗