SuperLine FX7010SWCRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI D755FX7010SWC0), received between Jul 21, 2017 and Aug 23, 2019 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX7010SWC WAS REMOVED ON (B)(6) 2019 DUE TO FAILURE TO OSSEOINTEGRATE 6 MONTHS AND 9 DAYS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE DOCTOR NOTED BONE RESORPTION DURING EXPLANTATION. THE PATIENT REQUIRED BONE AUGMENTATION FOR THE SURGERY. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8926359 ↗
• InjuryMay 23, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX7010SWC WAS REMOVED ON (B)(6) 2019 DUE TO FAILURE TO OSSEOINTEGRATE 1 MONTH AND 2 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 8637347 ↗
• InjuryMay 10, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX7010SWC WAS REMOVED ON (B)(6) 2018 DUE TO LOSS OF OSSEOINTEGRATION 1 YEAR AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE DOCTOR NOTED PERIODONTAL DISEASE DURING EXPLANTATION. THE PATIENT REQUIRED ANOTHER SURGICAL INTERVENTION TO RECOVER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8600541 ↗
• InjuryNov 12, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX7010SWC WAS REMOVED ON (B)(6) 2018 DUE TO FAILURE TO OSSEOINTEGRATE 1 MONTH AND 22 DAYS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT REQUIRED BONE AUGMENTATION (DFDBA COMBO) FOR THE SURGERY. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8062308 ↗
• InjuryOct 2, 2018Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX7010SWC WAS REMOVED ON (B)(6) 2018 DUE TO LOSS OF OSSEOINTEGRATION 3 YEARS AFTER IMPLANTATION. THE DOCTOR NOTED PERIODONTAL DISEASE DURING EXPLANTATION. THE PATIENT HAS HISTORY OF DIABETES AND HYPERTENSION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7928490 ↗
• InjuryJul 3, 2018Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX7010SWC WAS REMOVED ON (B)(6) 2018 DUE TO LOSS OF OSSEOINTEGRATION 1 YEAR AND 9 MONTHS AFTER IMPLANTATION. THE DOCTOR NOTED BONE RESORPTION DURING SURGERY. THE PATIENT HAS HISTORY OF DIABETES. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7661233 ↗
• InjuryApr 2, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX7010SWC WAS REMOVED ON (B)(6) 2017 DUE TO FAILURE TO OSSEOINTEGRATE 3 MONTHS AND 25 DAYS AFTER IMPLANTATION. THE DOCTOR DID NOT PROVIDE INFORMATION ABOUT THE PATIENT'S MEDICAL HISTORY. THE PATIENT REQUIRED ANOTHER SURGICAL INTERVENTION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7390911 ↗
• InjuryDec 1, 2017Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX7010SWC WAS REMOVED ON (B)(6) 2017 DUE TO LOSS OF OSSEOINTEGRATION 1 YEAR AND 6 MONTHS AFTER IMPLANTATION. THE DOCTOR INDICATED THAT BONE QUALITY MAY HAVE CAUSED THE IMPLANT REMOVAL. THE PATIENT HAS HISTORY OF DIABETES AND WILL REQUIRE ANOTHER MEDICAL INTERVENTION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7075741 ↗
• InjuryAug 16, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX7010SWC WAS REMOVED ON (B)(6) 2017 DUE TO FAILURE OF OSSEOINTEGRATION 2 MONTHS AND 2 WEEKS AFTER IMPLANTATION. THE DOCTOR INDICATED THAT LOCAL INFECTION CAUSED THE IMPLANT REMOVAL. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY AND HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 6797783 ↗
• InjuryJul 21, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX7010SWC WAS REMOVED ON (B)(6) 2017 DUE TO LOSS OF OSSEOINTEGRATION 3 MONTHS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT WILL REQUIRE ANOTHER SURGERY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 6734757 ↗