SuperLine FX4514SWCRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI D755FX4514SWC0), received between Nov 17, 2017 and Jul 24, 2023 — classified as 12 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2023Loss of Osseointegration; Loss of Osseointegration

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION, 6 YEARS AND 2 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE IV, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. NO SIGNIFICANT FINDING WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 17385603 ↗
• InjuryFeb 26, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE OSSEOINTEGRATION FAILURE 9 MONTHS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE 3, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. DURING THE SURGERY, BONE RESORPTION AND ABNORMAL SENSATION AROUND IMPLANT PLACEMENT WERE OBSERVED. PT. WILL LATER REQUIRE ANOTHER SURGICAL INTERVENTION.

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

  MAUDE report 11389414 ↗
• InjuryOct 14, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX4514SWC WAS REMOVED ON (B)(6) 2019 DUE TO LOSS OF OSSEOINTEGRATION 1 YEAR AND 11 MONTHS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF TOBACCO USE. THE PATIENT REQUIRED BONE AUGMENTATION FOR THE OPERATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9188014 ↗
• InjuryMay 20, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX4514SWC WAS REMOVED ON (B)(6) 2017 DUE TO LOSS OF OSSEOINTEGRATION 2 YEARS AND 1 MONTH AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF HYPERTENSION AND DIABETES. THE DOCTOR NOTED LOCAL INFECTION AND PAIN DURING EXPLANTATION. THE PATIENT REQUIRED ANOTHER SURGICAL INTERVENTION TO RECOVER.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 8625121 ↗
• InjuryMay 10, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX4514SWC WAS REMOVED ON (B)(6) 2018 DUE TO FAILURE TO OSSEOINTEGRATE 2 MONTHS AND 3 DAYS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE DOCTOR NOTED LOCAL INFECTION DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 8600403 ↗
• InjuryMar 28, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX4514SWC WAS REMOVED ON (B)(6) 2019 DUE TO FAILURE TO OSSEOINTEGRATE 19 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; Unspecified Infection

  MAUDE report 8462688 ↗
• InjuryJan 24, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX4514SWC WAS REMOVED ON (B)(6) 2018 DUE TO FAILURE TO OSSEOINTEGRATE 4 MONTHS AND 11 DAYS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF HYPERTENSION. THE DOCTOR NOTED BONE RESORPTION DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8274823 ↗
• InjuryJul 6, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX4514SWC WAS REMOVED ON (B)(6) 2018 DUE TO FAILURE TO OSSEOINTEGRATE 1 MONTH AND 20 DAYS 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 7666528 ↗
• InjuryJul 3, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX4514SWC WAS REMOVED ON (B)(6) 2018 DUE TO FAILURE TO OSSEOINTEGRATE 4 MONTHS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT REQUIRED ANOTHER SURGICAL INTERVENTION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7661214 ↗
• InjuryFeb 15, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX4514SWC WAS REMOVED ON (B)(6) 2017 DUE TO FAILURE TO OSSEOINTEGRATE WITHIN 2 MONTHS AND 17 DAYS AFTER IMPLANTATION. THE DOCTOR NOTED BONE RESORPTION DURING SURGERY. THE PATIENT HAS MEDICAL HISTORY OF HYPERTENSION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7273943 ↗
• InjuryNov 21, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX4514SWC WAS REMOVED ON (B)(6) 2017 DUE TO FAILURE TO OSSEOINTEGRATE 4 MONTHS AND 11 DAYS AFTER IMPLANTATION. THE DOCTOR INDICATED THAT BONE RESORPTION MAY HAVE CAUSED THE IMPLANT REMOVAL. THE PATIENT HAD A HISTORY OF HYPERTENSION AND TOBACCO USE AND HAS BEEN RECOVERED WITHOUT COMPLICATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7050421 ↗
• InjuryNov 17, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX4514SWC WAS REMOVED ON (B)(6) 2017 6 MONTHS AND 1 DAY AFTER IMPLANTATION DUE TO FAILURE TO OSSEOINTEGRATE. THE DOCTOR INDICATED THAT LOCAL INFECTION MAY HAVE 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 7041740 ↗