Neodent 140.897Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07899878018070), received between Nov 14, 2017 and Nov 4, 2019 — classified as 21 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (13 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2019Fracture; Fracture

  (B)(4) ¿ THE DENTIST REPORTED THAT 2 YEARS AND 6 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 13#, ITS FRACTURE WAS OBSERVED. MOREOVER, THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/QUANTITY.

  Patient problems: Failure of Implant; Tissue Damage

  MAUDE report 9272819 ↗
• InjuryOct 21, 2019Fracture; Fracture

  THE CLINICIAN REPORTED THAT OVER 2.5 YEARS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 11 IN THE PATIENT'S MOUTH, THE IMPLANT FRACTURED. THE CLINICIAN REPORTS THIS PATIENT'S INADEQUATE BONE QUALITY/QUANTITY. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: Failure of Implant

  MAUDE report 9215795 ↗
• 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 7868741 ↗
• InjuryJun 22, 2018Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THAT 2 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Tissue Damage

  MAUDE report 7629478 ↗
• InjuryMar 13, 2018Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTED 4.5 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 2, THE IMPLANT LOST OSSEOINTEGRATION IN TYPE III BONE. CLINICIAN REPORTS NON-COMPLIANCE WITH DIET. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 7336064 ↗
• InjuryMar 5, 2018Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTED THAT ABOUT 6 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 14, THE IMPLANT HAD NOT ACHIEVED OSSEOINTEGRATION IN TYPE II BONE. A 35 NCM OF TORQUE WAS ACHIEVED AT IMPLANT PLACEMENT. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 7314391 ↗
• InjuryFeb 28, 2018Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTED THAT, 5-6 MONTHS AFTER PLACEMENT IN SITE 19, THE IMPLANT WAS REMOVED. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS. (B)(4).

  Patient problems: Tissue Damage

  MAUDE report 7302372 ↗
• InjuryFeb 24, 2018Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTED THAT ALMOST 6 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 13, THE IMPLANT DID NOT ACHIEVE PRIMARY STABILITY OR OSSEOINTEGRATION. CLINICIAN REPORTS PAIN. THAT PATIENT IS A SMOKER. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS. (B)(4).

  Patient problems: Pain; Tissue Damage

  MAUDE report 7294249 ↗
• InjuryFeb 24, 2018Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTED THAT ALMOST 6 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 3, THE IMPLANT DID NOT ACHIEVE PRIMARY STABILITY OR OSSEOINTEGRATION. CLINICIAN REPORTS PAIN. THAT PATIENT IS A SMOKER. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS. (B)(4).

  Patient problems: Pain; Tissue Damage

  MAUDE report 7294246 ↗
• InjuryJan 22, 2018Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTED THAT ALMOST 4 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN TYPE II BONE IN ADA SITE 4, THE IMPLANT HAD NOT YET ACHIEVED PRIMARY STABILITY OR OSSEOINTEGRATION. CLINICIAN REPORTS PAIN. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS

  Patient problems: Pain; Tissue Damage

  MAUDE report 7210076 ↗
• InjuryJan 3, 2018Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration

  THE CLINICIAN REPORTED THAT NEARLY 1 MONTH AFTER THE DENTAL IMPLANT IN ADA SITE 13 WAS PLACED, THE IMPLANT LOST OSSEOINTEGRATION IN TYPE III BONE. NO INFECTION WAS PRESENT. A BONE GRAFT WAS COMPLETED AFTER THE IMPLANT REMOVAL. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 7162185 ↗
• InjuryDec 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER AN IMMEDIATE EXTRACTION OF THE TOOTH IN ADA SITE 4, THE CLINICIAN REPORTS THE IMPLANT AND ABUTMENT FAILED UPON INSERTION DUE TO LOW TORQUE. CLINICIAN REPORTS THE PATIENT BIT DOWN ON BLOCK AND FRACTURED FRONT WALL. A BONE GRAFT WAS PERFORMED IN TYPE III BONE. THE IMPLANT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 7100447 ↗
• InjuryNov 16, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT, 3 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #12; ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE PATIENT PRESENTED BONE TYPE I.

  Patient problems: Sinus Perforation; Tissue Damage

  MAUDE report 7036548 ↗
• 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. THERE IS NO INFORMATION ABOUT IMPLANT REPLACEMENT IN THE SAME SURGERY. THE IMPLANT WAS BEING INSTALLED IN INTRAORAL REGION #19.

  Patient problems: Tissue Damage

  MAUDE report 7035175 ↗
• InjuryNov 15, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) ¿ THE DENTIST REPORTED THAT, 5 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH; ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE PATIENT PRESENTED BONE TYPE II.

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 7032920 ↗
• InjuryNov 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CLINICIAN REPORTED THAT AT THE TIME OF DENTAL IMPLANT PLACEMENT IN ADA SITE 28 OF THE PATIENT¿S MOUTH, THERE WAS NON-OSSEOINTEGRATION AND LOW TORQUE. THE CLINICIAN REPORTS THAT INSUFFICIENT BONE QUALITY COULD HAVE INFLUENCED THE PROBLEM. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 7030117 ↗
• InjuryNov 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CLINICIAN REPORTED THAT THE IMPLANT WAS PLACED AND REMOVED ON THE SAME DAY IN ADA SITE 13 AS NO TORQUE WAS NOTED AND PRIMARY STABILITY WAS NOT ACHIEVED. ANOTHER IMPLANT WAS NOT PLACED AFTER REMOVAL ON THAT DAY. THE PATIENT'S BONE QUALITY WAS REPORTED TO BE TYPE II. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 7030079 ↗
• InjuryNov 14, 2017Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTED THAT SIX MONTHS AFTER THE DENTAL IMPLANT WAS PLACED, IN ADA SITE #13 OF THE PATIENT¿S MOUTH, NON-OSSEOINTEGRATION WAS OBSERVED. THE PATIENT PRESENTED WITH BONE TYPE III. PERI-IMPLANTITIS, INFECTION AND BONE RESORPTION WERE INVOLVED IN THE EVENT. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. PATIENT REPORTED PAIN AND SWELLING AT TIME OF EVENT, NO FURTHER COMPLICATIONS WERE OBSERVED.

  Patient problems: Pain; Swelling; Unspecified Infection

  MAUDE report 7029751 ↗
• 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 #4 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 7029232 ↗
• InjuryNov 14, 2017Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTED THAT 3 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE (B)(6)OF PATIENT'S MOUTH, NON-OSSEOINTEGRATION WAS OBSERVED. IT WAS REPORTED THAT AT TIME OF THE EVENT, THE PATIENT PRESENTED WITH MOBILITY. THE PATIENT PRESENTED WITH FAIR HYGIENE AROUND THE IMPLANT. IT WAS REPORTED THAT THE IMPLANT WAS NOT COVERED WITH BONE AND PRIMARY STABILITY HAD BEEN ACHIEVED. A PROFILE DRILL WAS REPORTED TO HAVE BEEN USED AND THE SITE WAS TAPPED PRIOR TO THE IMPLANT BEING MANUALLY PLACED.

  Patient problems: Tissue Damage

  MAUDE report 7029074 ↗
• InjuryNov 14, 2017Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTED THAT 4 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE #4 OF PATIENT'S MOUTH, NON-OSSEOINTEGRATION WAS OBSERVED. IT WAS REPORTED THAT AT TIME OF THE EVENT, THE PATIENT PRESENTED WITH PAIN AND MOBILITY. THE PATIENT PRESENTED WITH TYPE II BONE QUALITY AND THE HYGIENE AROUND THE IMPLANT WAS REPORTED TO BE GOOD. IT WAS REPORTED THAT THE IMPLANT WAS COVERED WITH BONE AND PRIMARY STABILITY HAD BEEN ACHIEVED. A PROFILE DRILL WAS REPORTED TO HAVE BEEN USED AND THE SITE WAS ...

  Patient problems: Pain; Tissue Damage

  MAUDE report 7029065 ↗