SuperLine FX3612SWCRecalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI D755FX3612SWC0), received between Dec 19, 2015 and May 4, 2026 — classified as 62 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (43 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2026Loss of Osseointegration

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION AFTER 1 YEAR, APPROXIMATELY 8 YEARS AND 5 MONTHS AFTER IMPLANT PLACEMENT. THE X-RAY WAS PROVIDED. THE BONE QUALITY WAS TYPE III. THE ORAL HYGIENE AROUND IMPLANT SITE WAS MODERATE. PERI-IMPLANTITIS WAS OBSERVED DURING THE REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS NOT USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT NEEDS ANOTHER SURGICAL INTERVENTION.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 25074705 ↗
• InjuryMay 4, 2026Loss of Osseointegration

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION AFTER 1 YEAR, APPROXIMATELY 4 YEARS AND 4 MONTHS AFTER IMPLANT PLACEMENT. THE X-RAY WAS PROVIDED. THE BONE QUALITY WAS TYPE III. THE ORAL HYGIENE AROUND IMPLANT SITE WAS MODERATE. BONE RESORPTION WAS OBSERVED DURING THE REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS NOT USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT NEEDS ANOTHER SURGICAL INTERVENTION.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 25074703 ↗
• InjuryDec 4, 2024Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN 1 YEAR, APPROXIMATELY 4 MONTHS AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS TYPE II. THE ORAL HYGIENE AROUND IMPLANT SITE WAS MODERATE. LOCAL INFECTION AND BONE RESORPTION WERE FOUND DURING THE REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS NOT USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.

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

  MAUDE report 20844973 ↗
• InjuryDec 4, 2024Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN 1 YEAR, APPROXIMATELY 8 MONTHS AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS TYPE II. THE ORAL HYGIENE AROUND IMPLANT SITE WAS MODERATE. PAIN AND ABNORMAL SENSATION WERE FOUND DURING THE REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS NOT USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Pain

  MAUDE report 20844937 ↗
• InjuryDec 4, 2024Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN 1 YEAR, APPROXIMATELY 5 MONTHS AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS TYPE II. THE ORAL HYGIENE AROUND IMPLANT SITE WAS MODERATE. BONE RESORPTION WAS FOUND DURING THE REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS NOT USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 20844449 ↗
• InjuryNov 6, 2024Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN 1 YEAR, APPROXIMATELY 3 MONTHS AFTER IMPLANT PLACEMENT. THE PATIENT'S X-RAY WAS PROVIDED. THE BONE QUALITY WAS TYPE II. THE ORAL HYGIENE AROUND IMPLANT SITE WAS GOOD. BONE RESORPTION WAS FOUND DURING THE REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS NOT USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 20625701 ↗
• InjuryApr 9, 2024Fracture; Fracture

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO IMPLANT FRACTURE APPROXIMATELY 1 YEAR AND 1 MONTH AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. LOCAL INFECTION, BONE RESORPTION AND PERI-IMPLANTTITIS WERE OBSERVED DURING REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS NOT USED IN IMPLANT PLACEMENT SURGERY. THERE WAS NO TRAUMA HISTORY TO PATIENT RELATED TO IMPLANT FRACTURE. THE PATIENT WILL NEED ANOTHER SURGICAL INTERVENTION.

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

  MAUDE report 19076651 ↗
• InjuryNov 1, 2023Fracture; Fracture

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO IMPLANT FRACTURE APPROXIMATELY 2 YEARS AND 11 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. BONE RESORPTION WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT WILL NEED ANOTHER SURGICAL INTERVENTION.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 18049022 ↗
• InjuryApr 7, 2023Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE AROUND 1 MONTH AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. PERI-IMPLANTITIS WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 16702836 ↗
• InjuryDec 29, 2022Loss of Osseointegration; Loss of Osseointegration

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY 1 YEAR AND 2 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. THE DOCTOR REPORTED NO SIGNIFICANT FINDINGS DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT NEEDS ANOTHER SURGICAL INTERVENTION.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 16075643 ↗
• InjuryDec 29, 2022Loss of Osseointegration; Loss of Osseointegration

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY 1 YEAR AND 2 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. THE DOCTOR REPORTED NO SIGNIFICANT FINDINGS DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT NEEDS ANOTHER SURGICAL INTERVENTION.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 16075638 ↗
• InjuryNov 17, 2022Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO FAILURE TO OSSEOINTEGRATE APPROXIMATELY 4 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. THE DOCTOR REPORTED BONE RESORPTION AND PERI-IMPLANTITIS WERE OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAD A RIDGE AUGMENTATION PROCEDURE (GBR) DONE ON TOOTH #6.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 15820989 ↗
• InjuryAug 20, 2022Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE AROUND EIGHT MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. BONE RESORPTION WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT WILL NEED ANOTHER SURGICAL INTERVENTION.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 15263140 ↗
• InjuryJun 10, 2022Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE AROUND SEVEN MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. LOCAL INFECTION WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.

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

  MAUDE report 14656009 ↗
• InjuryDec 13, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO FAILURE TO OSSEOINTEGRATE APPROXIMATELY 3 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. THE DOCTOR REPORTED BONE RESORPTION AND ABNORMAL SENSATION AROUND THE IMPLANT DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 12990382 ↗
• InjurySep 15, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE APPROXIMATELY 1 MONTH 5 DAYS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 12477926 ↗
• InjuryAug 20, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE APPROXIMATELY 5 MONTHS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE I, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. DURING THE SURGERY, BONE LOSS WAS REPORTED. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 12351655 ↗
• InjuryJul 13, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE APPROXIMATELY 1 MONTH AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE 2, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. DURING THE SURGERY BONE RESORPTION WAS OBSERVED. PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 12163621 ↗
• InjuryJun 3, 2021Loss of Osseointegration; Loss of Osseointegration

  THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY A YEAR 3 MONTHS 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 SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 11935975 ↗
• InjuryMay 2, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE APPROXIMATELY A MONTH AND A HALF AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE 3, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. DURING THE SURGERY, NO SIGNIFICANT FINDINGS WERE OBSERVED. PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 11758790 ↗
• InjuryJan 6, 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 8 MONTHS AFTER THE INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE IV, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. DURING THE SURGERY, THERE WERE NO SIGNIFICANT FINDINGS OBSERVED. PATIENT HAS SINCE RECOVERED.

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

  MAUDE report 11125015 ↗
• InjuryJan 3, 2021Use 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 13 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 problems: Failure of Implant; Inadequate Osseointegration; Patient Problem/Medical Problem

  MAUDE report 11106140 ↗
• InjuryDec 6, 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 8 MONTHS AFTER THE IMPLANT PLACEMENT DATE. ORAL HYGIENE AROUND THE IMPLANT SITE WAS MODERATE. 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 10955917 ↗
• InjuryDec 6, 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 5 MONTHS AFTER THE IMPLANT PLACEMENT DATE. ORAL HYGIENE AROUND THE IMPLANT SITE WAS MODERATE. BONE QUALITY AT SURGICAL SITE WAS TYPE 2. DURING THE SURGERY, PERIODONTAL DISEASE WAS OBSERVED.

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

  MAUDE report 10955916 ↗
• InjuryNov 24, 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 4 MONTHS AFTER THE IMPLANT PLACEMENT DATE. ORAL HYGIENE AROUND THE IMPLANT SITE WAS GOOD. BONE QUALITY AT SURGICAL SITE WAS TYPE 3. DURING THE SURGERY, NO SIGNIFICANT FINDINGS WERE OBSERVED.

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

  MAUDE report 10891104 ↗