SuperLine FX6012SWCRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI D755FX6012SWC0), received between May 31, 2017 and Dec 9, 2020 — classified as 6 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2020Use of Device Problem; Loss of Osseointegration; Osseointegration Problem; Use of Device Problem; Loss of Osseointegration; Osseointegration Problem

  THE DOCTOR REPORTED THAT IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION, APPROXIMATELY A YEAR AND A MONTH AFTER THE IMPLANT PLACEMENT DATE. ORAL HYGIENE AROUND THE IMPLANT SITE WAS GOOD. BONE QUALITY AT SURGICAL SITE WAS TYPE 4. DURING THE SURGERY, NO SIGNIFICANT FINDINGS WERE OBSERVED.

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

  MAUDE report 10978440 ↗
• InjurySep 11, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE 4 MONTHS AFTER PLACEMENT SURGERY. BONE QUALITY WAS TYPE II AND ORAL HYGIENE AT THE SITE OF THE IMPLANT WAS GOOD. DURING THE SURGERY, LOCAL INFECTION WAS OBSERVED.

  Patient problems: Inadequate Osseointegration; Patient Problem/Medical Problem; Unspecified Infection

  MAUDE report 10524091 ↗
• InjuryMay 10, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX6012SWC 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 8600631 ↗
• InjuryMay 10, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX6012SWC WAS REMOVED ON (B)(6) 2019 DUE TO LOSS OF OSSEOINTEGRATION 3 YEARS AND 5 MONTHS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF TOBACCO USE. THE DOCTOR NOTED PERIODONTAL DISEASE AND SINUS PERFORATION DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8600464 ↗
• InjuryMar 29, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT FX6012SWC WAS REMOVED ON (B)(6) 2019 DUE TO LOSS OF OSSEOINTEGRATION 1 YEAR AND 3 MONTHS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT REQUIRED ANOTHER SURGICAL INTERVENTION FOR RECOVERY.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 8464843 ↗
• InjuryMay 31, 2017Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE DENTAL IMPLANT, FX6012SWC WAS REMOVED ON (B)(6) 2017 DUE TO LOSS OF OSSEOINTEGRATION 1 YEAR AND 6 MONTHS AFTER IMPLANTATION. THE DOCTOR INDICATED THAT LOCAL INFECTION AND PAIN CAUSED THE IMPLANT REMOVAL. THE PATIENT HAS NO MEDICAL HISTORY. THE PATIENT HAS BEEN RECOVERED.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 6603651 ↗