Neodent 109.218Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07898237566818), received between Nov 9, 2017 and Oct 22, 2020 — classified as 8 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2020Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2014 IN THE PATIENT'S MOUTH. DETAILS OF SURGERY: IMMEDIATE EXTRACTION SITE. ON (B)(6) 2020, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH POOR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: SWELLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Swelling/ Edema

  MAUDE report 10720450 ↗
• InjuryAug 10, 2020Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2009 IN THE PATIENT'S MOUTH. ON (B)(6) 2009, 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 10386953 ↗
• InjuryJun 5, 2020Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN ADA 5. ON (B)(6) 2020, 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 10124425 ↗
• InjuryFeb 11, 2020Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) ¿ THE DENTIST REPORTED THAT 21 DAYS THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. MOREOVER, 15N.CM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/QUANTITY (BONE TYPE III), IMMEDIATE LOAD PROCEDURE WAS DONE AND IMMEDIATE IMPLANT WAS PERFORMED.

  Patient problems: Pain; Tissue Damage

  MAUDE report 9695580 ↗
• InjuryNov 14, 2017Loss of Osseointegration; Loss of Osseointegration

  (B)(4) - THE DENTIST REPORTED THAT, 3 YEARS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS LOSS OF OSSEOINTEGRATION WAS OBSERVED. A 50 NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/ QUANTITY.

  Patient problems: Tissue Damage

  MAUDE report 7029545 ↗
• InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THAT 18 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #11 IT WAS VERIFIED ITS NON- OSSEOINTEGRATION. A 30 NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Tissue Damage

  MAUDE report 7017399 ↗
• InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT ALMOST 2 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #5, IT WAS VERIFIED ITS NON- OSSEOINTEGRATION. 32 NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS NOT PERFORMED. THE PATIENT PRESENTED BONE TYPE III AND FENESTRATION OCCURRED DURING SURGERY.

  Patient problems: Pain; Tissue Damage

  MAUDE report 7016989 ↗
• InjuryNov 9, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT 6 MONTHS AFTER THREE DENTAL IMPLANTS WERE INSTALLED IN PATIENT'S MAXILE IT WAS VERIFIED THEIR NON- OSSEOINTEGRATION. FIFTEEN (15) NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS NOT EXECUTED. THE PATIENT PRESENTED BONE TYPE IV.

  Patient problems: Tissue Damage

  MAUDE report 7015391 ↗