Neodent 109.329Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07898237567143), received between Nov 9, 2017 and May 6, 2026 — classified as 12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2026Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN FDI 46. ON (B)(6) 2025, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: SWELLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Swelling/ Edema

  MAUDE report 25102798 ↗
• InjuryJun 26, 2025Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2001 IN FDI 11. ON (B)(6) 2025, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS, PAIN AND SWELLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Inflammation; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 22340321 ↗
• InjurySep 5, 2022Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN FDI 46. ON (B)(6) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15357326 ↗
• InjuryAug 4, 2022Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN FDI 36. DETAILS OF SURGERY: SINUS AUGMENTATION AND IMMEDIATE EXTRACTION SITE. ON (B)(6) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BRUXISM. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS, PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Fibrosis; Pain; Unspecified Infection

  MAUDE report 15166412 ↗
• InjuryAug 10, 2020Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2014 IN THE PATIENT'S MOUTH. ON (B)(6) 2014, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 10386941 ↗
• InjuryOct 28, 2019Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) ¿ THE DENTIST REPORTED THAT 3 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED.

  Patient problems: Tissue Damage

  MAUDE report 9243590 ↗
• InjuryOct 24, 2019Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Tissue Damage

  MAUDE report 9233166 ↗
• InjuryJun 6, 2019Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THAT HE PERFORMED THE DENTAL IMPLANT REMOVAL DURING ITS INSTALLATION SURGERY, BECAUSE NO PRIMARY STABILITY WAS ACHIEVED. THE IMPLANT WAS NOT REPLACED IN THE SAME SURGICAL ACT.

  Patient problems: Tissue Damage

  MAUDE report 8676654 ↗
• InjuryDec 20, 2018Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Tissue Damage

  MAUDE report 8185356 ↗
• InjurySep 19, 2018Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) THE DENTIST REPORTED THAT 21 DAYS AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 12#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, 25NCM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/QUANTITY, IMMEDIATE IMPLANT PROCEDURE WAS PERFORMED, FENESTRATION OCCURRED DURING SURGERY AND BONE GRAFT WAS EXECUTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Damage; Unspecified Infection

  MAUDE report 7891130 ↗
• InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THAT, 1 MONTH AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #18, ITS NON-OSSEOINTEGRATION WAS OBSERVED. EIGHTY NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE IMPLANT WAS IMMEDIATELY LOADED.

  Patient problems: Pain; Tissue Damage

  MAUDE report 7020592 ↗
• InjuryNov 9, 2017Loss of Osseointegration; Loss of Osseointegration

  (B)(4). THE DENTIST REPORTED THAT 1 YEAR AND 3 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #18 IT WAS VERIFIED ITS LOSS OF OSSEOINTEGRATION. A 45 NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS NOT EXECUTED. THE PATIENT PRESENTED BONE TYPE II.

  Patient problems: Pain; Tissue Damage

  MAUDE report 7015590 ↗