SuperLine FX7008SWCRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI D755FX7008SWC0), received between May 6, 2016 and Mar 20, 2021 — classified as 9 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2021Loss of Osseointegration; Loss of Osseointegration

  THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE LOSS OF OSSEOINTEGRATION APPROXIMATELY 4 YEARS 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 RECOVERED SINCE.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 11536666 ↗
• InjuryNov 19, 2020Use of Device Problem; Failure to Osseointegrate; Osseointegration Problem; Use of Device Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DOCTOR REPORTED THAT IMPLANT WAS REMOVED DUE TO FAILURE OF OSSEOINTEGRATION, APPROXIMATELY 3 MONTHS AFTER THE IMPLANT PLACEMENT DATE. ORAL HYGIENE AROUND THE IMPLANT SITE WAS POOR. BONE QUALITY AT SURGICAL SITE WAS TYPE 2. DURING THE SURGERY, PERIODONTAL DISEASE WAS OBSERVED. PATIENT HAS RECOVERED SINCE.

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

  MAUDE report 10871147 ↗
• InjurySep 6, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE LESS THAN A MONTH AFTER PLACEMENT SURGERY. BONE QUALITY WAS TYPE II AND ORAL HYGIENE AT THE SITE OF THE IMPLANT WAS MODERATE. DURING THE SURGERY, BONE RESORPTION WAS OBSERVED. THE PATIENT HAS RECOVERED.

  Patient problems: Inadequate Osseointegration; Patient Problem/Medical Problem

  MAUDE report 10498285 ↗
• InjuryAug 2, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX7008SWC WAS REMOVED ON (B)(6) 2019 FOR LOSS OF OSSEOINTEGRATION 1 YEAR AND 4 MONTHS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8857697 ↗
• InjuryJul 3, 2018Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX7008SWC WAS REMOVED ON (B)(6) 2018 DUE TO LOSS OF OSSEOINTEGRATION 1 YEAR AND 7 MONTHS AFTER IMPLANTATION. THE DOCTOR NOTED PERIODONTAL DISEASE DURING SURGERY. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7661290 ↗
• InjuryDec 18, 2017Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT (B)(4) WAS REMOVED ON (B)(6) 2017 DUE TO LOSS OF OSSEOINTEGRATION 2 YEARS AND 9 MONTHS AFTER THE DATE OF IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY AND HAS BEEN RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7126838 ↗
• InjuryJun 28, 2017Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX7008SWC WAS REMOVED ON (B)(6)2016 DUE TO LOSS OF OSSEOINTEGRATION AFTER 6 YEARS AND 6 MONTHS AFTER IMPLANTATION. THE DOCTOR INDICATE THAT LOCAL INFECTION AND BONE RESORPTION CAUSED IMPLANT REMOVAL. THE PATIENT HAS BEEN RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 6676014 ↗
• InjuryFeb 28, 2017Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT, FX7008SWC IN TOOTH LOCATION 9 WAS REMOVED ON (B)(6) 2016 DUE TO LOSS OF OSSEOINTEGRATION 2 YEARS AND 5 MONTHS AFTER IMPLANTATION. THE DOCTOR INDICATED THAT THE PATIENT'S POOR ORAL HYGIENE,PAIN AND INFECTION CAUSED THE IMPLANT REMOVAL. THE PATIENT HAD MEDICAL HISTORY OF DIABETIC. THE PATIENT HAS RECOVERED WITHOUT ANY COMPLICATIONS.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 6364724 ↗
• InjuryMay 6, 2016Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT, FX7008SWC IN TOOTH LOCATION #30 WAS REMOVED ON (B)(6) 2015 DUE TO LOSS OF OSSEOINTEGRATION AND INFECTION AFTER 1 YEAR 6 MONTHS IMPLANTATION. THE DOCTOR INDICATED THAT THE IMPLANT WAS REMOVED BECAUSE OF PATIENT HEALTH HABIT AND POOR ORAL HYGIENE. THE PATIENT HAS MEDICAL HISTORY, TOBACCO USE. THE CONDITION OF THE PATIENT IS RECOVERED WITHOUT COMPLICATIONS AND STABLE. NEW IMPLANT PLACEMENT IS SCHEDULED.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 5638433 ↗