SuperLine FX3614SWCRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI D755FX3614SWC0), received between Aug 15, 2017 and Oct 1, 2018 — classified as 5 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 1, 2018Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX3614SWC WAS REMOVED ON (B)(6) 2018 DUE TO LOSS OF OSSEOINTEGRATION 1 YEAR AND 5 MONTHS 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 7924612 ↗
• InjuryAug 31, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX3614SWC WAS REMOVED ON (B)(6) 2018 DUE TO FAILURE TO OSSEOINTEGRATE 7 MONTHS AND 4 DAYS AFTER IMPLANTATION. THE PATIENT REQUIRED BONE AUGMENTATION DURING THE SURGERY. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT HAS REQUIRED ANOTHER SURGICAL INTERVENTION TO RECOVER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7839783 ↗
• InjuryJul 3, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX3614SWC WAS REMOVED ON (B)(6) 2018 DUE TO FAILURE TO OSSEOINTEGRATE 6 MONTHS AND 16 DAYS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7661021 ↗
• InjuryNov 21, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT (B)(4) WAS REMOVED ON (B)(6) 2017 DUE TO FAILURE TO OSSEOINTEGRATE 2 MONTHS AND 22 DAYS AFTER IMPLANTATION. THE DOCTOR INDICATED THAT LOCAL INFECTION MAY HAVE CAUSED THE IMPLANT REMOVAL. THE PATIENT HAS A HISTORY OF HYPERTENSION AND DIABETES AND HAS BEEN RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 7051466 ↗
• InjuryAug 15, 2017Break; Loss of Osseointegration; Osseointegration Problem; Break; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX3614SWC WAS REMOVED ON (B)(6)2017 DUE TO LOSS OF OSSEOINTEGRATION 1 YEAR AND 2 MONTHS AFTER IMPLANTATION. UPON REMOVAL THE IMPLANT FRACTURED IN THE PATIENT'S MOUTH OBSERVED AT THE 9TH FIXTURE LEVEL THREAD. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY AND HAS BEE RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Discomfort; Inadequate Osseointegration

  MAUDE report 6795820 ↗