Neodent 140.896Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07899878018063), received between Nov 14, 2017 and Oct 21, 2022 — classified as 12 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (4 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.

• InjuryOct 21, 2022Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN ADA 20. ON (B)(6) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. 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 15652931 ↗
• InjuryOct 21, 2022Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN ADA 20. ON (B)(6) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. 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 15652136 ↗
• InjurySep 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) ¿ THE DENTIST REPORTED THAT HE HAD TO REMOVE THE DENTAL IMPLANT ON THE SAME DAY OF INSTALLATION SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Tissue Damage

  MAUDE report 7870665 ↗
• InjuryAug 29, 2018Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THAT 9 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 4 IN THE MOUTH, THE IMPLANT LOST OSSEOINTEGRATION IN TYPE II BONE. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 7827998 ↗
• InjuryJun 28, 2018Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTED THAT FOUR MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 3 IN THE MOUTH, THE IMPLANT HAD NOT ACHIEVED OSSEOINTEGRATION IN TYPE I BONE..THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS. (B)(4).

  Patient problems: Tissue Damage

  MAUDE report 7647687 ↗
• InjuryJun 12, 2018Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTED THAT 4.5 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 3 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION IN TYPE III BONE. CLINICIAN REPORTS INSUFFICIENT BONE QUALITY. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 7593758 ↗
• InjuryFeb 12, 2018Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THAT 5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 23, THE IMPLANT HAD NOT YET OBTAINED PRIMARY STABILITY. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 7264598 ↗
• InjuryFeb 12, 2018Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THAT 5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 26, THE IMPLANT HAD NOT YET OBTAINED PRIMARY STABILITY. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 7264597 ↗
• InjuryJan 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CLINICIAN REPORTS THE IMPLANT PLACED FAILED TO STABILIZE UPON INSERTION. ANOTHER IMPLANT WAS NOT SUCCESSFULLY PLACED IN THE SAME SITE ON THE SAME DAY. THE IMPLANT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 7187632 ↗
• InjuryDec 21, 2017Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTED THAT 7 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 2, LOSS OF OSSEOINTEGRATION WAS VERIFIED. A BONE GRAFT WAS PERFORMED WITH ALLOGRAFT. CLINICIAN NOTED FENESTRATION AND INSUFFICIENT BONE QUALITY IN TYPE III BONE. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 7137130 ↗
• InjuryNov 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). THE DENTIST REPORTED THAT, THE DENTAL IMPLANT WAS REMOVED DURING ITS INSTALLATION SURGERY BECAUSE NO PRIMARY STABILITY WAS ACHIEVED. THERE IS NO INFORMATION ABOUT IMPLANT REPLACEMENT IN THE SAME SURGICAL ACT.

  Patient problems: Tissue Damage

  MAUDE report 7035249 ↗
• InjuryNov 14, 2017Adverse 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 #2 OF THE PATIENT¿S MOUTH, A FAILURE OCCURRED UPON INSERTION. PRIMARY STABILITY WAS NOT ACHIEVED. PATIENT PRESENTED WITH TYPE III BONE. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 7029222 ↗