SuperLine FX5014SWCRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI D755FX5014SWC0), received between Mar 16, 2018 and Mar 2, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2022Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY 3 MONTHS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY WAS NOT RECORDED, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. THE DOCTOR REPORTED NO SIGNIFICANT FINDINGS DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS OTHER TREATMENT PLAN.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 13657053 ↗
• InjuryAug 25, 2021Loss of Osseointegration; Loss of Osseointegration

  THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY 6 YEARS-1 MONTH AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. DURING THE SURGERY, LOCAL INFECTION WAS REPORT. THE PATIENT HAS SINCE RECOVERED.

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

  MAUDE report 12368711 ↗
• InjuryJan 26, 2021Use of Device Problem; Failure to Osseointegrate; Osseointegration Problem; Use of Device Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY A MONTH AFTER THE INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE 2, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. DURING THE SURGERY, THERE WERE LOCAL INFECTION AND BONE RESORPTION OBSERVED. PATIENT WILL LATER NEED ANOTHER SURGICAL INTERVENTION.

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

  MAUDE report 11233922 ↗
• InjuryMay 10, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX5014SWC WAS REMOVED ON (B)(6) 2018 DUE TO FAILURE TO OSSEOINTEGRATE 6 MONTHS AND 20 DAYS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE DOCTOR NOTED LOCAL INFECTION DURING EXPLANTATION. THE PATIENT REQUIRED ANOTHER SURGICAL INTERVENTION TO RECOVER.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 8600566 ↗
• InjuryNov 27, 2018Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE PRODUCT INFORMATION PROVIDED BY THE DOCTOR DOES NOT MATCH THE ACTUAL RETURNED PRODUCT.

  Patient problems: Inadequate Osseointegration; Pain; Unspecified Infection

  MAUDE report 8107397 ↗
• InjuryAug 30, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX5014SWC WAS REMOVED ON (B)(6) 2018 DUE TO FAILURE TO OSSEOINTEGRATE 6 MONTHS AND 6 DAYS AFTER IMPLANTATION. THE DOCTOR NOTED LOCAL INFECTION DURING EXPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 7833226 ↗
• InjuryMar 16, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT FX5014SWC WAS REMOVED ON (B)(6) 2018 DUE TO FAILURE TO OSSEOINTEGRATE 26 DAYS AFTER IMPLANTATION. THE DOCTOR NOTED LOCAL INFECTION DURING THE SURGERY. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 7345519 ↗