SuperLineRecalls & reported problems across all models

We found 22 models of SuperLine by Dentium USA in the FDA's device registry (GUDID). Together they are named in 879 adverse event reports in the FDA's MAUDE database, received between Dec 19, 2015 and May 4, 2026 — classified as 879 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (659 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SuperLine problems

SuperLine models

22 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SuperLine FX4510SWC

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  129 reports
• SuperLine FX4010SWC

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  102 reports
• SuperLine FX3610SWC

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  93 reports
• SuperLine FX5010SWC

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  83 reports
• SuperLine FX4012SWC

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  70 reports
• SuperLine FX4508SWC

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  64 reports
• SuperLine FX3612SWC

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  62 reports
• SuperLine FX4512SWC

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  43 reports
• SuperLine FX4008SWC

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  37 reports
• SuperLine FX5008SWC

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  32 reports
• SuperLine FX6010SWC

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  24 reports
• SuperLine FX3608SWC

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  23 reports
• SuperLine FX5012SWC

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  23 reports
• SuperLine FX6008SWC

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  21 reports
• SuperLine FX4014SWC

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  20 reports
• SuperLine FX4514SWC

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  12 reports
• SuperLine FX7010SWC

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  10 reports
• SuperLine FX7008SWC

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  9 reports
• SuperLine FX5014SWC

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  7 reports
• SuperLine FX6012SWC

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  6 reports
• SuperLine FX3614SWC

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  5 reports
• SuperLine FX7012SWC

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  4 reports

Recent SuperLine adverse event reports

The 15 most recent reports across all models, 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, 2026Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN 1 YEAR, APPROXIMATELY 1 YEAR AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS TYPE III. THE ORAL HYGIENE AROUND IMPLANT SITE WAS GOOD. THE DOCTOR NOTED OSSEOINTEGRATION FAILURE WAS 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 25074704 ↗
• 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 ↗
• 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 BONE QUALITY WAS TYPE III. THE ORAL HYGIENE AROUND IMPLANT SITE WAS GOOD. LOCAL INFECTION WAS OBSERVED DURING THE 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; Unspecified Infection

  MAUDE report 23007846 ↗
• InjuryAug 19, 2025Loss of Osseointegration; Loss of Osseointegration

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY 3 YEARS AND 1 MONTH AFTER IMPLANT PLACEMENT. HE ALSO MENTIONED THAT THE IMPLANT WAS DEFORMED, AND SCREW WAS BROKEN AS WELL. WHEN DENTIUM STAFF, (B)(6), REACHED OUT FOR CLARIFICATION, AMANDA (SURGICAL ASSISTANT) EXPLAINED THAT THE IMPLANT WAS DIFFICULT TO REMOVE. THE STRENGTH OF FORCEPS CAUSED IMPRESSION ON THE FIXTURE, AND NOT THE FIXTURE ITSELF DEFORMING. THE BONE QUALITY WAS TYPE II. THE ORAL HYGIENE AROUND IMPLANT SITE WAS MODERATE. NO SIGNIFICANT FINDINGS WERE OBSERVED DURING THE IMPLANT 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 22845605 ↗
• InjuryAug 19, 2025Loss of Osseointegration; Loss of Osseointegration

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY 8 YEARS AND 6 MONTHS AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS TYPE II. THE ORAL HYGIENE AROUND IMPLANT SITE WAS MODERATE. BONE RESORPTION WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS USED IN IMPLANT PLACEMENT SURGERY. THE IMPLANT WAS REMOVED, AND THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 22845602 ↗
• InjuryAug 12, 2025Failure 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 MODERATE. NO SIGNIFICANT FINDINGS 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 22784906 ↗
• InjuryJun 10, 2025Failure 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 IV, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. LOCAL INFECTION AND PERI-IMPLANTITIS WERE OBSERVED DURING THE IMPLANT REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT WILL NEED ANOTHER SURGICAL INTERVENTION. THE DOCTOR DID A SOCKET PRESENTATION PROCEDURE AFTER THE IMPLANT CAME OUT.

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

  MAUDE report 22178408 ↗
• InjuryJun 3, 2025Failure 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 MODERATE. PAIN 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; Pain

  MAUDE report 22135158 ↗
• InjuryJun 3, 2025Failure 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. NO SIGNIFICANT FINDING WAS OBSERVED DURING THE IMPLANT 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 22135155 ↗
• InjuryJun 3, 2025Loss of Osseointegration; Loss of Osseointegration

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION, 5 YEARS AND 9 MONTHS AFTER IMPLANT PLACEMENT. X-RAY WAS PROVIDED. 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. 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 22135127 ↗
• InjuryJun 3, 2025Loss of Osseointegration; Loss of Osseointegration

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION, 5 YEARS AND 9 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. 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 22135124 ↗
• InjuryMay 13, 2025Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, 7 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS POOR. PERIODONTAL DISEASE, BONE RESORPTION AND PERI-IMPLANTITIS 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 22015378 ↗
• InjuryMay 13, 2025Loss of Osseointegration; Loss of Osseointegration

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO INFECTION OF NEIGHERING TOOTH SPREAD TO IMPLANT AROUND 2 YEARS AND 6 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. LOCAL INFECTION, PERIODONTAL DISEASE, 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; Unspecified Infection

  MAUDE report 22015377 ↗
• InjuryMay 12, 2025Failure 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 III, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. 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 22006828 ↗

Other Dentium USA products

• SuperLine II23 models · 424 reports
• Implantium15 models · 221 reports