Neodent 109.640Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07898237568881), received between Nov 9, 2017 and Apr 28, 2022 — classified as 20 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (16 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 16, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2022Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN FDI 17. ON (B)(6) 2022, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III AND INADEQUATE BONE QUALITY/QUANTITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 14242028 ↗
• InjuryMar 18, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN ADA 2. ON (B)(6) 2021, NON-OSSEOINTEGRATION WAS VERIFIED. 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 11518418 ↗
• InjuryMar 18, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN ADA 2. ON (B)(6) 2021, NON-OSSEOINTEGRATION WAS VERIFIED. 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 11517694 ↗
• InjuryJun 11, 2020Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN FDI 46. ON (B)(6) 2018, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH INADEQUATE BONE QUALITY/QUANTITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 10144533 ↗
• InjuryApr 12, 2019Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTED ALMOST 6 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 27 IN THE MOUTH, IT DID NOT ACHIEVE OSSEOINTEGRATION IN TYPE I BONE. CLINICIAN NOTED THE PATIENT'S DEHISCENCE IN THIS IMMEDIATE EXTRACTION SITE. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 8511535 ↗
• InjuryDec 28, 2018Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT 1 MONTH AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, 35NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED INSUFFICIENT BONE QUANTITY/QUALITY (BONE TYPE III).

  Patient problems: Tissue Damage

  MAUDE report 8204715 ↗
• InjuryJan 27, 2018Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTED THAT 16 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED, IN INTRAORAL SITE 10 OF THE PATIENT¿S MOUTH, BONE LOSS WAS OBSERVED AROUND THE IMPLANT. INITIAL PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS PERFORMED. PATIENT PRESENTED BONE TYPE III. PATIENT DID EXPERIENCE PAIN. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: Pain; Tissue Damage

  MAUDE report 7223844 ↗
• InjuryJan 27, 2018Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTED THAT 16 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED, IN INTRAORAL SITE 7 OF THE PATIENT¿S MOUTH, BONE LOSS WAS OBSERVED AROUND THE IMPLANT. INITIAL PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS PERFORMED. PATIENT PRESENTED BONE TYPE II. PATIENT DID EXPERIENCE PAIN. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: Pain

  MAUDE report 7223841 ↗
• InjuryNov 15, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THAT, 2 WEEKS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. A 35 NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE IMPLANT WAS IMMEDIATELY LOADED. THE PATIENT PRESENTED BONE TYPE IV.

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 7033179 ↗
• InjuryNov 15, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT, 5 MONTHS AFTER TWO DENTAL IMPLANTS WERE INSTALLED IN INTRAORAL REGION #13 AND #4, THEIR NON-OSSEOINTEGRATION WAS OBSERVED. THE IMPLANTS WERE IMMEDIATELY LOADED AND THE PATIENT PRESENTED BONE TYPE II.

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 7032285 ↗
• InjuryNov 15, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT, 2 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #20, ITS NON-OSSEOINTEGRATION WAS OBSERVED.

  Patient problems: Tissue Damage

  MAUDE report 7032237 ↗
• InjuryNov 14, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) ¿ THE DENTIST REPORTED THAT, 8 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. A 35 NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS PERFORMED. THE PATIENT PRESENTED BONE TYPE II AND BONE GRAFT WAS EXECUTED.

  Patient problems: Fistula; Tissue Damage; Unspecified Infection

  MAUDE report 7030702 ↗
• InjuryNov 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) - THE DENTIST REPORTED THAT HE HAD TO REMOVED THE DENTAL IMPLANT DURING ITS INSTALLATION SURGERY BECAUSE ITS LACK OF PRIMARY STABILITY.

  Patient problems: Tissue Damage

  MAUDE report 7027398 ↗
• InjuryNov 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) - THE DENTIST REPORTED THAT HE HAD TO REMOVED THE DENTAL IMPLANT DURING ITS INSTALLATION SURGERY BECAUSE ITS LACK OF PRIMARY STABILITY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Tissue Damage

  MAUDE report 7027393 ↗
• 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 #28, 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 7021524 ↗
• InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT, 1 WEEK AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. FORTY (40) NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOAD. THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/ QUANTITY (BONE TYPE I).

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 7021494 ↗
• InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THAT, 2 WEEKS AFTER TWO DENTAL IMPLANTS WERE INSTALLED IN PATIENT¿S MOUTH, THEIR NON-OSSEOINTEGRATION WAS OBSERVED. THIRTY-FIVE NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE IMPLANTS WERE IMMEDIATELY LOADED. THE PATIENT PRESENTED BONE TYPE IV.

  Patient problems: Pain; Swelling; Tissue Damage

  MAUDE report 7021478 ↗
• InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THAT, 1 WEEK AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #24, ITS NON-OSSEOINTEGRATION WAS OBSERVED. FORTY NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOAD. THE PATIENT PRESENTED BONE TYPE II.

  Patient problems: Fistula; Tissue Damage; Unspecified Infection

  MAUDE report 7020041 ↗
• InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT, 10 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, NON-OSSEOINTEGRATION WAS OBSERVED. 40 NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS NOT PERFORMED. THE PATIENT PRESENTED BONE TYPE I.

  Patient problems: Tissue Damage

  MAUDE report 7018877 ↗
• InjuryNov 9, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THAT 20 DAYS AFTER TWO DENTAL IMPLANTS WERE INSTALLED IN INTRAORAL REGION #23 AND #26, IT WAS VERIFIED THEIR NON-OSSEOINTEGRATION. THE 35 NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS PERFORMED. THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/QUANTITY (BONE TYPE IV).

  Patient problems: Tissue Damage

  MAUDE report 7013003 ↗