SuperLine FX4508SWCRecalls & reported problems
Dentium USA · Endosseous dental implant · Class 2 · Implant
Quick summary
This Dentium SuperLine FX4508SWC is a root-form endosseous dental implant placed in the jawbone. The 64 reports mostly describe the implant failing to fuse with the surrounding bone, so it had to be removed within weeks or months of placement, sometimes with local infection, bone loss and pain. All 64 reports involve injuries, with no deaths mentioned. 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
- 64
- Deaths reported
- 0
- Injuries reported
- 64
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI D755FX4508SWC0), received between Mar 26, 2016 and Feb 3, 2025 — classified as 64 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (56 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 Osseointegrate56
- Osseointegration Problem49
- Loss of Osseointegration7
- Use of Device Problem5
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Inadequate Osseointegration62
- Failure of Implant20
- Unspecified Infection12
- Patient Problem/Medical Problem9
- Pain6
Recent adverse event reports
The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.
InjuryFeb 3, 2025Failure 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 III. ORAL HYGIENE AROUND IMPLANT SITE WAS MODERATE. NO SIGNIFICANT FINDING 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 21297757 ↗InjuryFeb 3, 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 III. ORAL HYGIENE AROUND IMPLANT SITE WAS MODERATE. NO SIGNIFICANT FINDING 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 21297688 ↗InjuryApr 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN 1 YEAR, AROUND 1 MONTH AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS TYPE III. THE ORAL HYGIENE AROUND IMPLANT SITE WAS GOOD. LOCAL INFECTION, BONE RESORPTION AND PAIN WERE OBSERVED DURING THE REMOVAL SURGERY. THE PATIENT WILL NEED ANOTHER SURGICAL INTERVENTION.
Patient problems: Failure of Implant; Inadequate Osseointegration; Pain; Unspecified Infection
MAUDE report 19154473 ↗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. BONE RESORPTION WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 19028842 ↗InjuryNov 30, 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 IV, 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 18242384 ↗InjuryJul 14, 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 IV, 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 17329475 ↗InjuryDec 13, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO FAILURE TO OSSEOINTEGRATE APPROXIMATELY 1 MONTH AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE IV, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. THE DOCTOR REPORTED 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 15973931 ↗InjuryAug 25, 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 IV, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. DURING THE SURGERY, NO SIGNIFICANT FINDING WAS REPORTED. THE PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 12368555 ↗InjuryJun 18, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE APPROXIMATELY 7 MONTHS AND THREE WEEKS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE 1, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. DURING THE SURGERY, NO SIGNIFICANT FINDINGS WERE OBSERVED. PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 12026278 ↗InjuryJun 3, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE APPROXIMATELY 11 MONTHS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE 1, 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 11936056 ↗InjuryMay 2, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO OSSEOINNTEGRATION FAILURE APPROXIMATELY A MONTH 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 11758785 ↗InjuryMar 20, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE APPROXIMATELY 6 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 AND PERIODONTAL DISEASE WERE OBSERVED. PATIENT HAS RECOVERED SINCE.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 11536675 ↗InjuryMar 20, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE OSSEOINTEGRATION FAILURE APPROXIMATELY 4 MONTHS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE 2, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. DURING THE SURGERY, NO SIGNIFICANT FINDINGS WERE OBSERVED. PATIENT HAS RECOVERED SINCE.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 11536671 ↗InjuryFeb 26, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE OSSEOINTEGRATION FAILURE LESS THAN A MONTH AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE 3, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. DURING THE SURGERY, NO SIGNIFICANT FINDINGS WERE OBSERVED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Patient Problem/Medical Problem
MAUDE report 11389413 ↗InjuryFeb 15, 2021Use of Device Problem; Loss of Osseointegration; Osseointegration Problem; Use of Device Problem; Loss of Osseointegration; Osseointegration Problem
THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE LOSS OF OSSEOINTEGRATION APPROXIMATELY 1 YEAR AND 1 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 AND PAIN WERE OBSERVED. PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Pain; Patient Problem/Medical Problem
MAUDE report 11330563 ↗InjuryJan 3, 2021Use 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 FIVE AND HALF MONTHS AFTER THE IMPLANT PLACEMENT DATE. ORAL HYGIENE AROUND THE IMPLANT SITE WAS MODERATE. BONE QUALITY AT SURGICAL SITE WAS TYPE 3. DURING THE SURGERY, PATIENT COMPLAINED OF PAIN; HOWEVER, PATIENT HAS SINCE RECOVERED.
Patient problems: Failure of Implant; Inadequate Osseointegration; Pain; Patient Problem/Medical Problem
MAUDE report 11106125 ↗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 TO OSSEOINTEGRATE, APPROXIMATELY 6 MONTHS AFTER THE IMPLANT PLACEMENT DATE. ORAL HYGIENE AROUND THE IMPLANT SITE WAS MODERATE. BONE QUALITY AT SURGICAL SITE WAS TYPE 4. DURING THE SURGERY, NO SIGNIFICANT FINDINGS WERE OBSERVED. PATIENT HAS RECOVERED SINCE.
Patient problems: Failure of Implant; Inadequate Osseointegration; Patient Problem/Medical Problem
MAUDE report 10955928 ↗InjuryNov 19, 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 A MONTH 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 10871198 ↗InjuryNov 19, 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 6 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, BONE RESORPTION WAS OBSERVED. PATIENT HAS RECOVERED SINCE.
Patient problems: Failure of Implant; Inadequate Osseointegration; Patient Problem/Medical Problem
MAUDE report 10871149 ↗InjurySep 6, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE 9 MONTHS AFTER PLACEMENT SURGERY. BONE QUALITY WAS TYPE II AND ORAL HYGIENE AT THE SITE OF THE IMPLANT WAS MODERATE. DURING THE SURGERY, PERIODONTAL DISEASE WAS OBSERVED. THE PATIENT HAS RECOVERED.
Patient problems: Inadequate Osseointegration; Patient Problem/Medical Problem
MAUDE report 10498293 ↗InjurySep 6, 2020Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE 21 MONTHS AFTER PLACEMENT SURGERY. BONE QUALITY WAS TYPE II AND ORAL HYGIENE AT THE SITE OF THE IMPLANT WAS MODERATE. DURING THE SURGERY, BONE RESORPTION WAS OBSERVED. THE PATIENT HAS RECOVERED.
Patient problems: Inadequate Osseointegration; Patient Problem/Medical Problem
MAUDE report 10498287 ↗InjurySep 4, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE LESS THAN A MONTH AFTER PLACEMENT SURGERY. BONE QUALITY WAS TYPE II AND ORAL HYGIENE AT THE SITE OF THE IMPLANT WAS GOOD. DURING THE SURGERY, BONE RESORPTION AND PERIODONTAL DISEASE WAS OBSERVED. THE PATIENT HAS RECOVERED.
Patient problems: Patient Problem/Medical Problem; Unspecified Infection
MAUDE report 10496174 ↗InjuryAug 31, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
DENTAL IMPLANT FX4508SWC WAS REMOVED ON (B)(6) 2020 DUE TO OSSEOINTEGRATION FAILURE AROUND 6 MONTHS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF DIABETES, HYPERTENSION, AND DRUG ABUSE. DURING THE SURGERY, PERIODONTAL DISEASE AND BONE RESORPTION WAS OBSERVED. THE PATIENT RECOVERED.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 10474928 ↗InjuryMay 18, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
THE DENTAL IMPLANT FX4508SWC WAS REMOVED ON (B)(6) 2020 DUE TO FAILURE TO OSSEOINTEGRATE 23 DAYS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF DIABETES. THE DOCTOR NOTED PERIODONTAL DISEASE AND PAIN DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 10067911 ↗InjuryApr 28, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem
THE DENTAL IMPLANT FX4508SWC WAS REMOVED ON (B)(6) 2020 DUE TO OSSEOINTEGRATION FAILURE AROUND 7 MONTHS AND 6 DAYS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF DIABETES. THE DOCTOR NOTED PERIODONTAL DISEASE DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.
Patient problems: Inadequate Osseointegration
MAUDE report 10005934 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.