Neodent 140.655Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07899878016670), received between Nov 9, 2017 and May 18, 2026 — classified as 19 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (15 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 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2026Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN FDI 37. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED, IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE AND IMMEDIATE EXTRACTION SITE. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Fibrosis

  MAUDE report 25208155 ↗
• InjuryJan 2, 2025Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN FDI 25. DETAILS OF SURGERY: IMMEDIATE EXTRACTION SITE. ON (B)(6) 2024, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION, SWELLING AND FISTULA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Fistula; Swelling/ Edema; Unspecified Infection

  MAUDE report 21059618 ↗
• InjurySep 27, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN FDI 21. DETAILS OF SURGERY: IMMEDIATE EXTRACTION SITE. ON (B)(6) 2021, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III AND INADEQUATE BONE QUALITY/QUANTITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12535864 ↗
• InjuryDec 21, 2020Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN FDI 37. ON (B)(6) 2020, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE IV AND INADEQUATE BONE QUALITY/QUANTITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY AND SWELLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Fibrosis; Swelling/ Edema

  MAUDE report 11049394 ↗
• InjuryMar 13, 2020Loss of Osseointegration; Loss of Osseointegration

  (B)(4) ¿ THE DENTIST REPORTED THAT APPROXIMATELY 1 YEAR AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 19#, ITS LOSS OF OSSEOINTEGRATION WAS OBSERVED. MOREOVER, THE PATIENT PRESENTED BONE TYPE II.

  Patient problems: Tissue Damage

  MAUDE report 9828658 ↗
• InjuryMar 6, 2020Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN ADA 19. ON (B)(6) 2019, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.

  Patient problems: Tissue Damage

  MAUDE report 9797435 ↗
• InjuryApr 8, 2019Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) ¿ THE DENTIST REPORTED THAT 21 DAYS MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED.

  Patient problems: Pain; Tissue Damage; Unspecified Infection

  MAUDE report 8490884 ↗
• InjuryMar 25, 2019Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4)¿ THE DENTIST REPORTED THAT 1 MONTH AND 3 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 4#, ITS NON- OSSEOINTEGRATION WAS OBSERVED. MOREOVER, 45N.CM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE II, BONE GRAFT WAS PLACED, IMMEDIATE IMPLANT WAS PERFORMED AND IMMEDIATE LOAD PROCEDURE WAS DONE.

  Patient problems: Pain; Tissue Damage

  MAUDE report 8447650 ↗
• InjuryDec 11, 2018Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT 1 MONTH AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 20#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. MOREOVER, 50NCM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE II, TRAUMA OVER THE IMPLANT HAS OCCURRED AND IMMEDIATE LOAD AND IMMEDIATE IMPLANT PROCEDURES WERE PERFORMED.

  Patient problems: Pain; Tissue Damage

  MAUDE report 8153012 ↗
• InjuryDec 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CLINICIAN REPORTED THAT ON THE DAY THE DENTAL IMPLANT WAS PLACED IN ADA SITE 29 IN THE MOUTH, THE DRIVER BROKE INSIDE THE IMPLANT. CLINICIAN NOTED THE IMPLANT HAD TO BE CUT OUT DUE TO DENSE BONE. ANOTHER IMPLANT WAS NOT PLACED IN THE SAME SITE ON THE SAME DAY. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 8143493 ↗
• InjuryOct 22, 2018Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTED THAT 2 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 5 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEO- INTEGRATION. CLINICIAN NOTED PATIENT'S PAIN AND SWELLING. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.

  Patient problems: Pain; Swelling; Tissue Damage

  MAUDE report 7993093 ↗
• InjuryApr 17, 2018Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTED THAT 4 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 19, THE IMPLANT HAD NOT ACHIEVED OSSEOINTEGRATION IN TYPE II BONE. CLINICIAN REPORTS MOBILITY DURING TORQUING. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS. (B)(4).

  Patient problems: Tissue Damage

  MAUDE report 7437697 ↗
• InjuryFeb 26, 2018Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THAT, 4 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #30, ITS NON-OSSEOINTEGRATION WAS OBSERVED.

  Patient problems: Tissue Damage

  MAUDE report 7297954 ↗
• InjuryDec 19, 2017Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration

  THE CLINICIAN REPORTED THAT SIX MONTHS AFTER THE DENTAL IMPLANT WAS PLACED, IN INTRAORAL SITE #13 OF THE PATIENT¿S MOUTH, NON- OSSEOINTEGRATION WAS OBSERVED. PRIMARY STABILITY WAS NOT ACHIEVED AND IMMEDIATE LOAD WAS NOT PERFORMED. PATIENT PRESENTED BONE TYPE IV AND TONGUE PRESSURE AND TENDERNESS. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS. (B)(4).

  Patient problems: Tissue Damage

  MAUDE report 7128262 ↗
• InjuryNov 15, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT, 5 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. FORTY NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE IMPLANT WAS IMMEDIATELY LOADED. THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/ QUANTITY (BONE TYPE II).

  Patient problems: Tissue Damage

  MAUDE report 7035421 ↗
• InjuryNov 15, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT, ALMOST 2 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #15, ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE IMPLANT WAS IMMEDIATELY LOADED AND THE PATIENT PRESENTED BONE TYPE II.

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 7035300 ↗
• InjuryNov 14, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE CLINICIAN REPORTED THAT 11 DAYS AFTER THE DENTAL IMPLANT WAS PLACED IN THE PATIENT'S MOUTH NON-OSSEOINTEGRATION WAS OBSERVED. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 7030139 ↗
• InjuryNov 14, 2017Difficult to Remove; Difficult to Remove

  THE CLINICIAN REPORTED WHEN IMPLANT WAS PLACED IN ADA SITE 14 OF THE PATIENT'S MOUTH, A LOCAL INFECTION WAS PRESENT. A BONE GRAFT WAS EXECUTED ON TYPE III BONE. PRIMARY STABILITY WAS NOT OBTAINED AND MOBILITY WAS PRESENT. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT INJURIES OR OPERATIVE (OR POST-OPERATIVE) COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 7029696 ↗
• InjuryNov 9, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT 20 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #5 IT WAS VERIFIED ITS NON-OSSEOINTEGRATION. IMMEDIATE LOAD WAS EXECUTED AND THE PATIENT PRESENTED BONE TYPE II.

  Patient problems: Pain; Tissue Damage

  MAUDE report 7015784 ↗