Neodent 109.527Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07898237567815), received between Feb 8, 2018 and Oct 13, 2022 — classified as 11 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryOct 13, 2022Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN ADA 16. ON (B)(6) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN, MOBILITY AND INCREASED SENSITIVITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Fibrosis; Hyperresponsive to stimuli; Pain

  MAUDE report 15598666 ↗
• InjuryJul 25, 2022Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN FDI 26. ON (B)(6) 2022, LOSS OF 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 15097411 ↗
• InjuryJul 25, 2022Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN FDI 23. ON (B)(6) 2022, LOSS OF 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 15097329 ↗
• InjuryDec 15, 2020Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN ADA 4. ON (B)(6) 2020, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III AND POOR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Fibrosis; Pain

  MAUDE report 11006252 ↗
• InjuryDec 14, 2020Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED ON (B)(6) 2020 IN ADA 4. ON (B)(6) 2020, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III AND POOR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Fibrosis; Pain

  MAUDE report 11004737 ↗
• InjuryMar 30, 2020Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT ALMOST 1 MONTH AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS LOSS OF OSSEOINTEGRATION WAS OBSERVED.

  Patient problems: Tissue Damage

  MAUDE report 9899345 ↗
• InjuryMay 15, 2019Loss of Osseointegration; Loss of Osseointegration

  (B)(4). THE DENTIST REPORTED THAT 2 YEARS AND 5 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #14, ITS LOSS OF OSSEOINTEGRATION WAS OBSERVED. MOREOVER, 50N.CM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE III AND IMMEDIATE LOAD PROCEDURE WAS PERFORMED.

  Patient problems: Pain; Tissue Damage

  MAUDE report 8612379 ↗
• InjuryMar 14, 2019Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) ¿ THE DENTIST REPORTED THAT 6 MONTHS AND 2 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 13#, ITS NON- OSSEOINTEGRATION WAS OBSERVED. MOREOVER, 50N.CM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED BONE TYPE I.

  Patient problems: Tissue Damage

  MAUDE report 8422761 ↗
• InjuryFeb 19, 2019Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) ¿ THE DENTIST REPORTED THAT THE DENTAL IMPLANT HAS NOT OSSEOINTEGRATED, BUT HE DID NOT PROVIDED FURTHER INFORMATION ABOUT THE CASE.

  Patient problems: Tissue Damage

  MAUDE report 8351513 ↗
• InjuryApr 5, 2018Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THAT 8 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 7#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, THE PATIENT PRESENTED BONE TYPE IV, 40NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS PERFORMED.

  Patient problems: Pain; Tissue Damage

  MAUDE report 7400263 ↗
• InjuryFeb 8, 2018Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT 3 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. THIRTY-FIVE (35) NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOAD. THE PATIENT PRESENTED BONE TYPE I.

  Patient problems: Pain; Tissue Damage; Unspecified Infection

  MAUDE report 7251532 ↗