SuperLine FX5010SWCRecalls & reported problems
Dentium USA · Endosseous dental implant · Class 2 · Implant
Quick summary
This DENTIUM SuperLine dental implant replaces a missing tooth root. The 83 adverse event reports, all injuries and no deaths, mostly describe implants that never fused with the jawbone or later loosened, often requiring removal surgery, sometimes with infection or pain. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 83
- Deaths reported
- 0
- Injuries reported
- 83
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI D755FX5010SWC0), received between Oct 19, 2016 and Jun 10, 2025 — classified as 83 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (60 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.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate60
- Osseointegration Problem48
- Loss of Osseointegration19
- Adverse Event Without Identified Device or Use Problem3
- Use of Device Problem3
- Material Fragmentation1
Patient problems
- Inadequate Osseointegration79
- Failure of Implant38
- Unspecified Infection23
- Patient Problem/Medical Problem7
- Pain5
- Post Operative Wound Infection1
Recent adverse event reports
The 25 most recent of 83 reports, in the reporter's own words as published by the FDA.
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 ↗InjuryMay 12, 2025Failure 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. 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 22006822 ↗InjuryAug 14, 2024Loss of Osseointegration; Loss of Osseointegration
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION, 1 YEARS AND 3 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS POOR. PERI-IMPLANTITIS 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 19987583 ↗InjuryFeb 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, AROUND 4 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 18773657 ↗InjuryFeb 12, 2024Loss of Osseointegration; Loss of Osseointegration
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION, 6 YEARS AND 7 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. BONE RESORPTION WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 18692040 ↗InjuryNov 30, 2023Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE,14 DAYS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. 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 18242383 ↗InjuryAug 1, 2023Loss of Osseointegration; Loss of Osseointegration
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION 4 YEAS AND 9 MONTHS AFTER IMPLANT PLACEMENT SURGERY. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. THE DOCTOR REPORTED BONE RESORPTION AND PAIN WERE OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Pain
MAUDE report 17436672 ↗InjuryJul 10, 2023Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, AROUND 4 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 HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 17293868 ↗InjuryJun 23, 2023Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, AROUND 4 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 17195362 ↗InjuryMay 1, 2023Failure 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 II, 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 16845180 ↗InjuryJan 27, 2023Loss of Osseointegration; Loss of Osseointegration
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, 2 YEARS AND 6 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE I, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. BONE RESORPTION WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 16257639 ↗InjuryJan 10, 2023Failure 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. NO SIGNIFICANT FINDING WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 16135034 ↗InjuryDec 13, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, AROUND TWO MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. BONE RESORPTION AND PAIN WERE OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Pain
MAUDE report 15973862 ↗InjuryDec 13, 2022Failure 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 II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. NO SIGNIFICANT FINDINGS WERE OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 15972829 ↗InjurySep 8, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION, THREE 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 15383983 ↗InjuryJul 19, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, SIX MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. LOCAL INFECTION, BONE RESORPTION AND PERI-IMPLANTITIS WERE OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Unspecified Infection
MAUDE report 15060240 ↗InjuryMay 20, 2022Loss of Osseointegration; Loss of Osseointegration
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION AFTER ONE YEAR, ONE YEAR AND ONE MONTH AFTER IMPLANT PLACEMENT SURGERY. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. BONE RESORPTION AND PAIN WERE REPORTED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Pain
MAUDE report 14458304 ↗InjuryMay 20, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN ONE YEAR, AROUND 4 MONTHS AFTER IMPLANT PLACEMENT SURGERY. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. NO SIGNIFICANT FINDINGS WERE REPORTED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 14457740 ↗InjuryFeb 17, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN ONE YEAR, 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 LOCAL INFECTION DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Unspecified Infection
MAUDE report 13552745 ↗InjuryJan 5, 2022Loss of Osseointegration; Loss of Osseointegration
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY 1 YEAR - 2 1/2 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. THE DOCTOR REPORTED LOCAL INFECTION DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT WILL REQUIRE ANOTHER SURGICAL INTERVENTION.
Patient problems: Failure of Implant; Inadequate Osseointegration; Unspecified Infection
MAUDE report 13162514 ↗InjuryOct 25, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO FAILURE TO OSSEOINTEGRATION APPROXIMATELY 3 AND A HALF MONTHS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. NO SIGNIFICANT FINDINGS WERE REPORTED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 12694144 ↗InjurySep 17, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO INSUFFICIENT PRIMARY STABILITY, HOWEVER, IT WAS ALSO ASSESSED IN THE ASPECT OF OSSEOINTEGRATION FAILURE AS THE IMPLANT WAS EXPLANTED APPROXIMATELY 6 WEEKS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. LOCAL INFECTION AROUND THE IMPLANT PLACEMENT AREA WAS REPORTED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Unspecified Infection
MAUDE report 12492908 ↗InjurySep 14, 2021Loss of Osseointegration; Loss of Osseointegration
THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY 2 YEARS 3 MONTHS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS POOR. DURING THE IMPLANT REMOVAL SURGERY, BONE RESORPTION AROUND IMPLANT PLACEMENT WAS REPORTED. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 12471894 ↗InjuryAug 10, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE APPROXIMATELY 1 MONTH AND A HALF AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. DURING THE SURGERY PAIN WAS REPORTED. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Pain
MAUDE report 12305168 ↗InjuryAug 10, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO LOSS OF OSSEOINTEGRATION APPROXIMATELY 8 YEARS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE II, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. DURING THE SURGERY BONE RESORPTION AND PERI-IMPLANTITIS WAS REPORTED. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Post Operative Wound Infection
MAUDE report 12305125 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.