SuperLine FX5012SWCRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI D755FX5012SWC0), received between Nov 6, 2017 and Jun 27, 2024 — classified as 23 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2024Loss of Osseointegration; Loss of Osseointegration

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION, 9 YEARS AND 4 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. 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 19628234 ↗
• InjuryJun 30, 2023Loss of Osseointegration; Loss of Osseointegration

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION, 4 YEARS AND 4 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE IV, 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 17243624 ↗
• InjurySep 14, 2021Loss of Osseointegration; Loss of Osseointegration

  THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY 1 YEAR 3 WEEKS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS POOR. DURING THE IMPLANT REMOVAL SURGERY, PERIODONTAL DISEASE AROUND IMPLANT PLACEMENT WAS REPORTED. THE PATIENT HAS SINCE RECOVERED.

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

  MAUDE report 12471895 ↗
• InjurySep 14, 2021Loss of Osseointegration; Loss of Osseointegration

  THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY 2 YEARS 8 MONTHS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. DURING THE IMPLANT REMOVAL SURGERY ABNORMAL SENSATION AROUND IMPLANT PLACEMENT WAS REPORTED. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 12471892 ↗
• InjurySep 14, 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 II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. DURING THE IMPLANT REMOVAL SURGERY ABNORMAL SENSATION AROUND IMPLANT PLACEMENT WAS REPORTED. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 12471891 ↗
• InjuryJul 13, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE APPROXIMATELY 1 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 SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 12163456 ↗
• InjuryApr 16, 2021Loss of Osseointegration; Loss of Osseointegration

  THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION 1 YEAR AND 3 MONTHS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE 4, 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 11680628 ↗
• InjuryJan 3, 2021Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTED THAT IMPLANT WAS REMOVED BECAUSE PATIENT WAS EXPERIENCING LOCALIZED PAIN 2 WEEKS AFTER IMPLANT PLACEMENT, AS WELL HAS OBSERVATION OF MOBILITY ON THE IMPLANT. ORAL HYGIENE AROUND THE IMPLANT SITE WAS GOOD. BONE QUALITY AT SURGICAL SITE WAS TYPE 2. DURING THE SURGERY, PAIN AND ABNORMAL SENSATION AROUND IMPLANT PLACEMENT WERE OBSERVED. PATIENT HAS SINCE RECOVERED.

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

  MAUDE report 11106144 ↗
• InjurySep 25, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO FAILURE TO OSSEOINTEGRATE 4 MONTHS SINCE THE DATE OF SURGERY. ORAL HYGIENE AT THE SITE OF THE IMPLANT WAS MODERATE. DURING THE SURGERY, LOCAL INFECTION WAS OBSERVED. PATIENT HAS RECOVERED SINCE.

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

  MAUDE report 10587747 ↗
• InjurySep 25, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO FAILURE TO OSSEOINTEGRATE 7 MONTHS AFTER PLACEMENT SURGERY. ORAL HYGIENE AT THE SITE OF THE IMPLANT WAS POOR. BONE QUALITY AT SITE OF SURGERY WAS TYPE 2. DURING THE SURGERY, BONE RESORPTION WAS OBSERVED.

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

  MAUDE report 10587737 ↗
• InjuryAug 13, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX5012SWC WAS REMOVED ON (B)(6) 2020 DUE TO FAILURE TO OSSEOINTEGRATE 1 MONTH AND 18 DAYS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF BRUXISM. THE PATIENT REQUIRED BONE AUGMENTATION FOR THE OPERATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10405357 ↗
• InjuryApr 28, 2020Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX5012SWC WAS REMOVED ON (B)(6) 2019 DUE TO LOSS OF OSSEOINTEGRATION AROUND 3 YEARS AND 8 MONTHS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF TOBACCO USE AND HYPERTENSION. THE DOCTOR NOTED PERIODONTAL DISEASE DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10005848 ↗
• InjuryMar 4, 2020Loss of Osseointegration; Loss of Osseointegration

  THE DENTAL IMPLANT FX5012SWC WAS REMOVED ON (B)(6) 2019 DUE TO LOSS OF OSSEOINTEGRATION 1 YEAR AND 4 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 9789399 ↗
• InjuryJan 2, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX5012SWC WAS REMOVED ON (B)(6) 2019 DUE TO FAILURE TO OSSEOINTEGRATE 6 MONTHS AND 6 DAYS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE DOCTOR NOTED BONE RESORPTION DURING EXPLANTATION. THE PATIENT REQUIRED BONE AUGMENTATION FOR THE OPERATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9540951 ↗
• InjuryJan 2, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX5012SWC WAS REMOVED ON (B)(6) 2019 DUE TO FAILURE TO OSSEOINTEGRATE 7 MONTHS AND 24 DAYS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE DOCTOR NOTED BONE RESORPTION DURING EXPLANTATION. THE PATIENT REQUIRED ANOTHER SURGICAL INTERVENTION TO RECOVER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9540920 ↗
• InjuryMay 13, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX5012SWC WAS REMOVED ON (B)(6) 2019 DUE TO FAILURE TO OSSEOINTEGRATE 5 MONTHS AND 14 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 8604278 ↗
• InjuryMay 10, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX5012SWC WAS REMOVED ON (B)(6) 2019 DUE TO FAILURE TO OSSEOINTEGRATE 9 MONTHS AND 14 DAYS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE DOCTOR NOTED BONE RESORPTION DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8600606 ↗
• InjuryJul 12, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX5012SWC WAS REMOVED ON (B)(6) 2018 DUE TO FAILURE TO OSSEOINTEGRATE 6 MONTHS AND 2 DAYS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT REQUIRED ANOTHER SURGICAL INTERVENTION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7682061 ↗
• InjuryJun 20, 2018Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX5012SWC WAS REMOVED ON (B)(6) 2018 DUE TO LOSS OF OSSEOINTEGRATION 1 YEAR AND 3 MONTHS AFTER IMPLANTATION. THE DOCTOR NOTED BONE RESORPTION DURING SURGERY. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7620940 ↗
• InjuryMay 23, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX5012SWC WAS REMOVED ON (B)(6) 2018 DUE TO FAILURE TO OSSEOINTEGRATE 3 MONTHS AND 26 DAYS AFTER IMPLANTATION. THE PATIENT IS A TOBACCO USER BUT HAS NO OTHER SIGNIFICANT MEDICAL HISTORY. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7539069 ↗
• InjuryJan 12, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX5012SWC WAS REMOVED ON (B)(6) 2017 DUE TO FAILURE TO OSSEOINTEGRATE 1 MONTH AND 7 DAYS AFTER IMPLANTATION. THE THE DOCTOR INDICATED THAT DENTAL HYGIENE AROUND THE IMPLANT WAS POOR AND BONE QUALITY WAS TYPE III. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY AND WILL REQUIRE ADDITIONAL SURGICAL INTERVENTION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7186266 ↗
• InjuryDec 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DENTAL IMPLANT (B)(4) WAS REMOVED ON (B)(6) 2017 DUE TO INSUFFICIENT PRIMARY STABILITY ON THE DAY OF IMPLANTATION. THE PATIENT HAS NO SIGNIGICANT MEDICAL HISTORY AND IS ROCEVRING WITHOUT COMPLICATIONS.

  Patient problems: Failure of Implant

  MAUDE report 7127024 ↗
• InjuryNov 6, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX5012SWC WAS REMOVED ON (B)(6) 2017 DUE TO FAILURE TO OSSEOINTEGRATE 16 DAYS AFTER IMPLANTATION. THE PATIENT HAD HISTORY OF DIABETES AND HAS BEEN RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7004045 ↗