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SuperLine FX5008SWCRecalls & reported problems

Dentium USA · Endosseous dental implant · Class 2 · Implant

Quick summary

This Dentium SuperLine FX5008SWC is a root-form endosseous dental implant placed in the jawbone. The 32 reports mostly describe the implant failing to fuse with the surrounding bone, so it loosened or became infected and had to be removed, sometimes within weeks of placement, with bone loss and pain noted during removal surgery. There are 32 injuries and no deaths. 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
32
Deaths reported
0
Injuries reported
32
Recalls naming it
0

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI D755FX5008SWC0), received between Aug 8, 2017 and Sep 12, 2023 — classified as 32 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (27 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

Device problems

  • Failure to Osseointegrate27
  • Osseointegration Problem23
  • Loss of Osseointegration4
  • Use of Device Problem3
  • Material Fragmentation1

Patient problems

  • Inadequate Osseointegration31
  • Failure of Implant11
  • Unspecified Infection6
  • Patient Problem/Medical Problem4
  • Pain2

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

  • InjurySep 12, 2023Failure to Osseointegrate; Failure to Osseointegrate

    THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO PAIN AND INFECTION APPROXIMATELY 2 WEEKS AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS TYPE II. THE ORAL HYGIENE AROUND IMPLANT SITE WAS MODERATE. LOCAL INFECTION AND PAIN WERE OBSERVED 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; Unspecified Infection

    MAUDE report 17731699 ↗
  • InjuryJun 27, 2022Loss of Osseointegration; Loss of Osseointegration

    THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, ONE YEAR AND THREE MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE I, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. NO SIGNIFICANT FINDINGS WERE OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT WILL NEED ANOTHER SURGICAL INTERVENTION.

    Patient problems: Failure of Implant; Inadequate Osseointegration

    MAUDE report 14832056 ↗
  • InjuryApr 22, 2022Failure to Osseointegrate; Failure to Osseointegrate

    THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE AROUND 16 DAYS AFTER IMPLANT PLACEMENT SURGERY. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. THE DOCTOR REPORTED BONE RESORPTION DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.

    Patient problems: Failure of Implant; Inadequate Osseointegration

    MAUDE report 14188233 ↗
  • InjuryApr 22, 2022Failure to Osseointegrate; Failure to Osseointegrate

    THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE AROUND 45 DAYS AFTER IMPLANT PLACEMENT SURGERY. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. THE DOCTOR REPORTED BONE RESORPTION DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.

    Patient problems: Failure of Implant; Inadequate Osseointegration

    MAUDE report 14188205 ↗
  • InjuryDec 13, 2021Failure to Osseointegrate; Failure to Osseointegrate

    THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO FAILURE TO OSSEOINTEGRATE APPROXIMATELY 4 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE IV, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. THE DOCTOR REPORTED LOCAL INFECTION AND PERIODONTAL DISEASE DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT HAS SINCE RECOVERED.

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

    MAUDE report 12990282 ↗
  • InjuryJul 19, 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 IV, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. DURING THE SURGERY BONE RESORPTION AND IMPLANT MOBILITY WAS OBSERVED. PATIENT HAS SINCE RECOVERED.

    Patient problems: Failure of Implant; Inadequate Osseointegration

    MAUDE report 12193979 ↗
  • InjuryJul 14, 2021Failure to Osseointegrate; Failure to Osseointegrate

    THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE APPROXIMATELY 3 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 WAS OBSERVED. PATIENT HAS SINCE RECOVERED.

    Patient problems: Failure of Implant; Inadequate Osseointegration

    MAUDE report 12170085 ↗
  • InjuryFeb 21, 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 3, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. DURING THE SURGERY, NO SIGNIFICANT FINDINGS WERE OBSERVED. PATIENT WILL LATER REQUIRE ANOTHER SURGICAL INTERVENTION.

    Patient problems: Failure of Implant; Inadequate Osseointegration; Patient Problem/Medical Problem

    MAUDE report 11356871 ↗
  • InjuryFeb 15, 2021Material Fragmentation; Use of Device Problem; Material Fragmentation; Use of Device Problem

    THE DOCTOR REPORTED THAT THE IMPLANT WAS REMOVED DUE TO ABUTMENT DAMAGE APPROXIMATELY 2 YEARS AND 6 MONTHS AFTER INITIAL IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE 2, 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; Patient Problem/Medical Problem

    MAUDE report 11330548 ↗
  • 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 11106127 ↗
  • InjuryDec 9, 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 7 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, PERIODONTAL DISEASE WAS OBSERVED. PATIENT HAS RECOVERED SINCE.

    Patient problems: Failure of Implant; Inadequate Osseointegration; Patient Problem/Medical Problem

    MAUDE report 10978404 ↗
  • InjuryJul 8, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

    THE DENTAL IMPLANT FX5008SWC WAS REMOVED ON (B)(6) 2020 DUE TO FAILURE TO OSSEOINTEGRATE 17 DAYS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT REQUIRED BONE AUGMENTATION FOR THE OPERATION. THE DOCTOR NOTED PERIODONTAL DISEASE DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

    Patient problems: Inadequate Osseointegration

    MAUDE report 10246700 ↗
  • InjuryMay 18, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

    THE DENTAL IMPLANT FX5008SWC WAS REMOVED ON (B)(6) 2020 DUE TO FAILURE TO OSSEOINTEGRATE 1 MONTH AND 19 DAYS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF TOBACCO USE AND HYPERTENSION. THE DOCTOR NOTED PERIODONTAL DISEASE AND BONE RESORPTION DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

    Patient problems: Inadequate Osseointegration

    MAUDE report 10067929 ↗
  • InjuryApr 28, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

    THE DENTAL IMPLANT FX5008SWC WAS REMOVED ON (B)(6) 2020 DUE TO OSSEOINTEGRATION FAILURE AROUND 4 MONTHS AND 21 DAYS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF TOBACCO USE AND DIABETES. THE DOCTOR NOTED PERIODONTAL DISEASE DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

    Patient problems: Inadequate Osseointegration

    MAUDE report 10005895 ↗
  • InjuryFeb 24, 2020Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

    THE DENTAL IMPLANT FX5008SWC WAS REMOVED ON (B)(6) 2019 DUE TO LOSS OF OSSEOINTEGRATION 2 YEARS AND 1 MONTH AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF DIABETES. THE DOCTOR NOTED LOCAL INFECTION DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

    Patient problems: Inadequate Osseointegration; Unspecified Infection

    MAUDE report 9745606 ↗
  • InjuryFeb 24, 2020Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

    THE DENTAL IMPLANT FX5008SWC WAS REMOVED ON (B)(6) 2019 DUE TO LOSS OF OSSEOINTEGRATION 1 YEAR AND 13 DAYS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF TOBACCO USE, HYPERTENSION, AND DIABETES. THE DOCTOR NOTED PERIODONTAL DISEASE DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

    Patient problems: Inadequate Osseointegration

    MAUDE report 9745573 ↗
  • InjuryFeb 10, 2020Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

    THE DENTAL IMPLANT FX5008SWC WAS REMOVED ON (B)(6) 2020 DUE TO FAILURE TO OSSEOINTEGRATE 2 MONTHS AND 24 DAYS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF TOBACCO USE. THE DOCTOR NOTED BONE RESORPTION DURING EXPLANTATION. THE PATIENT REQUIRED BONE AUGMENTATION FOR THE OPERATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

    Patient problems: Inadequate Osseointegration

    MAUDE report 9690083 ↗
  • InjuryNov 12, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

    THE DENTAL IMPLANT FX5008SWC WAS REMOVED ON (B)(6) 2019 DUE TO FAILURE TO OSSEOINTEGRATE 4 MONTHS AND 24 DAYS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE DOCTOR NOTED PERIODONTAL DISEASE AND BONE RESORPTION DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

    Patient problems: Inadequate Osseointegration

    MAUDE report 9311953 ↗
  • InjuryMay 30, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

    THE DENTAL IMPLANT FX5008SWC WAS REMOVED ON (B)(6) 2019 DUE TO FAILURE TO OSSEOINTEGRATE 27 DAYS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT REQUIRED BONE AUGMENTATION FOR THE OPERATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

    Patient problems: Inadequate Osseointegration

    MAUDE report 8654806 ↗
  • InjuryMay 23, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

    THE DENTAL IMPLANT FX5008SWC WAS REMOVED ON (B)(6) 2019 DUE TO FAILURE TO OSSEOINTEGRATE 2 MONTHS AND 6 DAYS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT REQUIRED ANOTHER SURGICAL INTERVENTION TO RECOVER.

    Patient problems: Inadequate Osseointegration

    MAUDE report 8637155 ↗
  • InjuryMay 13, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

    THE DENTAL IMPLANT FX5008SWC WAS REMOVED ON (B)(6) 2018 DUE TO FAILURE TO OSSEOINTEGRATE 23 DAYS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE DOCTOR NOTED LOCAL INFECTION AND PAIN DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

    Patient problems: Inadequate Osseointegration; Unspecified Infection

    MAUDE report 8604355 ↗
  • InjuryApr 16, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

    THE DENTAL IMPLANT (B)(4) WAS REMOVED ON (B)(6) 2019 DUE TO FAILURE TO OSSEOINTEGRATE 1 MONTH AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT REQUIRED BONE AUGMENTATION FOR THE OPERATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

    Patient problems: Inadequate Osseointegration

    MAUDE report 8520646 ↗
  • InjuryApr 16, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

    THE DENTAL IMPLANT FX5008SWC WAS REMOVED ON (B)(6) 2019 DUE TO LOSS OF OSSEOINTEGRATION 2 YEARS AND 2 MONTHS AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF BRUXISM AND ALLERGY TO TITANIUM. THE DOCTOR NOTED BONE RESORPTION DURING THE SURGERY. THE PATIENT REQUIRED BONE AUGMENTATION FOR THE OPERATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

    Patient problems: Inadequate Osseointegration

    MAUDE report 8520619 ↗
  • InjuryMar 13, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

    THE DENTAL IMPLANT FX5008SWC WAS REMOVED ON (B)(6) 2019 DUE TO FAILURE TO OSSEOINTEGRATE 4 MONTHS AND 10 DAYS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT REQUIRED BONE AUGMENTATION FOR THE SURGERY. THE DOCTOR NOTED LOCAL INFECTION DURING EXPLANTATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

    Patient problems: Inadequate Osseointegration; Unspecified Infection

    MAUDE report 8417763 ↗
  • InjuryMar 6, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

    THE DENTAL IMPLANT FX5008SWC WAS REMOVED ON (B)(6) 2019 DUE TO FAILURE TO OSSEOINTEGRATE 6 MONTHS AND 7 DAYS AFTER IMPLANTATION. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY. THE PATIENT REQUIRE BONE AUGMENTATION FOR THE SURGERY. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

    Patient problems: Inadequate Osseointegration

    MAUDE report 8397370 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.