SuperLine II FXS4012CRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI D755FXS4012C0), received between Jul 19, 2021 and Jun 11, 2026 — classified as 23 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (21 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2026Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN 1 YEAR, APPROXIMATELY 17 DAYS AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS TYPE II. THE ORAL HYGIENE AROUND IMPLANT SITE WAS MODERATE. PAIN WAS FOUND DURING THE REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Pain

  MAUDE report 25480280 ↗
• InjuryJun 2, 2026Loss of Osseointegration

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY 1 YEAR AND 11 MONTHS AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS NOT PROVIDED. THE ORAL HYGIENE AROUND IMPLANT SITE WAS MODERATE. PERIODONTAL DISEASE AND BONE RESORPTION WERE OBSERVED DURING THE IMPLANT REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 25368311 ↗
• InjuryApr 1, 2026Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN 1 YEAR, APPROXIMATELY 5 MONTHS AFTER IMPLANT PLACEMENT. PATIENT'S X-RAY WAS PROVIDED. THE BONE QUALITY WAS TYPE III. THE ORAL HYGIENE AROUND IMPLANT SITE WAS NOT REPORTED. BONE RESORPTION AND PAIN WERE FOUND DURING THE REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS NOT USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT WILL NEED ANOTHER SURGICAL INTEVENTION.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Pain

  MAUDE report 24756651 ↗
• InjuryMar 6, 2026Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN 1 YEAR, APPROXIMATELY 10 MONTHS AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS TYPE III. THE ORAL HYGIENE AROUND IMPLANT SITE WAS MODERATE. PERI-IMPLANTITIS AND LOCAL INFECTION WERE OBSERVED DURING THE 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; Unspecified Infection

  MAUDE report 24533771 ↗
• InjurySep 9, 2025Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN 1 YEAR, APPROXIMATELY 2 MONTHS AFTER IMPLANT PLACEMENT. THE X-RAY WAS PROVIDED. THE BONE QUALITY WAS TYPE II. THE ORAL HYGIENE AROUND IMPLANT SITE WAS GOOD. NO SIGNIFICANT FINDINGS WERE OBSERVED 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 23009036 ↗
• InjurySep 9, 2025Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN 1 YEAR, APPROXIMATELY 10 MONTHS AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS TYPE III. THE ORAL HYGIENE AROUND IMPLANT SITE WAS POOR. BONE RESORPTION AND PERI-IMPLANTITIS WERE OBSERVED DURING THE 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 23007864 ↗
• InjuryNov 19, 2024Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, 2 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. LOCAL INFECTION WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.

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

  MAUDE report 20728849 ↗
• InjuryJul 5, 2024Osseointegration Problem; Osseointegration Problem

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO INSUFFICIENT PRIMARY STABILITY, 14 DAYS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. NO SIGNIFICANT FINDING WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 19684790 ↗
• InjuryMay 1, 2024Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, 4 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. PERI-IMPLANTITIS AND PERIODONTAL DISEASE WERE OBSERVED DURING THE IMPLANT REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS NOT USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT WILL NEED ANOTHER SURGICAL INTERVENTION.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 19226877 ↗
• InjuryApr 2, 2024Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, 3 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. LOCAL INFECTION AND ABNORMAL SENSATION AROUND IMPLANT PLACEMENT WERE OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT WILL NEED ANOTHER SURGICAL INTERVENTION.

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

  MAUDE report 19029421 ↗
• InjuryDec 29, 2023Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, 3 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. LOCAL INFECTIN AND ABNORMAL SENSATION AROUND IMPLANT PLACEMENT WERE OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT WILL NEED ANOTHER SURGICAL INTERVENTION.

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

  MAUDE report 18419467 ↗
• InjuryAug 29, 2023Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, 3 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE I, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. PAIN WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT WILL NEED ANOTHER SURGICAL INTERVENTION.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Pain

  MAUDE report 17647275 ↗
• InjuryAug 2, 2023Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, 3 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. LOCAL INFECTION, BONE RESORPTION, PERIODONTAL DISEASE, PERI IMPLANTITIS WERE OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT WILL NEED ANOTHER SURGICAL INTERVENTION.

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

  MAUDE report 17439955 ↗
• InjuryJun 30, 2023Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, 5 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. NO SIGNIFICANT FINDING WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 17243586 ↗
• InjuryMar 24, 2023Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, 1 MONTH AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. PERI-IMPLANTITIS WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT WILL NEED ANOTHER SURGICAL INTERVENTION.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 16611545 ↗
• InjuryMar 21, 2023Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, 2 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. PERI-IMPLANTITIS WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT WILL NEED ANOTHER SURGICAL INTERVENTION.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 16580085 ↗
• InjuryAug 15, 2022Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, AROUND 8 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. MOBILITY WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS USED ON IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 15230380 ↗
• InjuryAug 15, 2022Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, AROUND THREE MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE IV, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. PERI-IMPLANTITIS AND IMPLANT MOBILITY WERE OBSERVED DURING THE IMPLANT REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS USED ON IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 15230357 ↗
• InjuryAug 15, 2022Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, AROUND 8 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. MOBILITY WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS USED ON IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 15230354 ↗
• InjuryApr 22, 2022Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE AROUND 5 MONTHS AFTER IMPLANT PLACEMENT SURGERY. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. NO SIGNIFICANT FINDING WAS REPORTED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 14188238 ↗
• InjuryMar 8, 2022Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN ONE YEAR, APPROXIMATELY 1 MONTH AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE IV, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. THE DOCTOR REPORTED LOCAL INFECTION DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.

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

  MAUDE report 13697662 ↗
• InjuryNov 24, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO FAILURE TO OSSEOINTEGRATE APPROXIMATELY 3 WEEKS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. THE DOCTOR REPORTED LOCAL INFECTION WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT WILL REQUIRE ANOTHER SURGICAL INTERVENTION.

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

  MAUDE report 12869370 ↗
• InjuryJul 19, 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 II AND III, 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 12193943 ↗