SuperLine II FXS3614CRecalls & reported problems
Dentium USA · Endosseous dental implant · Class 2 · Implant
All models of SuperLine II (23)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI D755FXS3614C0), received between Jan 22, 2025 and Mar 11, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (2 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.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate2
Patient problems
- Failure of Implant2
- Inadequate Osseointegration2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 11, 2025Failure 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 III. THE ORAL HYGIENE AROUND IMPLANT SITE WAS GOOD. NO FINDING WAS FOUND DURING THE REMOVAL SURGERY AND MOVEMENT DURING IMPRESSION. BONE AUGMENTATION MATERIAL WAS USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 21579677 ↗InjuryJan 22, 2025Failure 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. ORAL HYGIENE AROUND IMPLANT SITE WAS GOOD. PERI-IMPLANTITIS WAS FOUND 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 21211010 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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