3i T3® DCD® BNSS410Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00844868029038), received between Feb 17, 2020 and Jun 11, 2026 — classified as 27 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2026Patient-Device Incompatibility

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO ALLERGIC REACTION. PATIENT REPORTED EDEMA AND DISCOMFORT ON X-RAY APPEARED TO BE ELICITING A REACTION AND BONE WAS RESORBING. TOOTH NUMBER 30. #30 IMPLANT REMOVED AND GRAFTED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, DISCOMFORT AND EDEMA.

  Patient problems: Discomfort; Hypersensitivity/Allergic reaction; Pain

  MAUDE report 25479129 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A BURNING SENSATION ON THE PATIENT'S LIP, AS WELL AS SEVERE NUMBNESS AT THE TOOTH SITE #18. IT WAS OPTED TO REMOVE THE IMPLANT. THE SITE WAS NOT GRAFTED IN CASE THE NERVE WAS EXPOSED AND NOT FURTHER DISCOMFORT THE PATIENT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain

  MAUDE report 24060045 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRESCRIBED ANTIBIOTICS DUE TO AN INFECTION AT TOOTH SITE #14 (UNIVERSAL). SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN AND SWELLING.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 22864927 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 22861886 ↗
• InjuryAug 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO INFECTION AND INADEQUATE POSITIONING. THE PATIENT HAD FREQUENT INFECTIONS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN AND SWELLING.

  Patient problems: Unspecified Infection

  MAUDE report 22824577 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. AT FOLLOW UP APPOINTMENT GENERAL DENTIST REPORTED SWELLING AND PAIN #21. XRAY WAS TAKEN SHOWING PERIODICAL LUCENCY SITE#21. IMPLANT WAS REMOVED. TOOTH SITE: 21. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND SWELLING, INFLAMMATION.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 22333065 ↗
• InjuryMay 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #30 BROKE WHILE THE PATIENT WAS EATING. THE IMPLANT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994563 ↗
• InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED INFECTION. FISTULA FOUND ON BUCCAL #13, BUCCAL PLATE MISSING DOWN TO APEX. #13 IMPLANT REMOVED, SITE GRAFTED AND OSSEOGUARD MEMBRANE PLACED. SYMPTOMS AS A RESULT OF THE EVENT: FISTULA.

  Patient problems: Fistula; Unspecified Infection

  MAUDE report 21333184 ↗
• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. AT SECOND PO PATIENT REPORTING CONTINUAL DISCOMFORT AND OCCASIONAL NUMBNESS AS IF GIVEN NOVOCAIN. IMPLANT DROPPED 5MM INTO SPACE THAT HAD FORMED DUE TO INFECTION. TOOTH NUMBER 19. ADDITIONAL APPOINTMENT REQUIRED FOR PATIENT TO HAVE DENTURE DISTAL. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.

  Patient problems: Erosion; Pain; Unspecified Infection

  MAUDE report 21327868 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER #35 & #36 FAILED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20046253 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS GIVEN ANTIBIOTIC FOR INFECTION. TOOTH SITES #28 AND #30.SYMPTOMS AS A RESULT OF THE EVENT: PAIN & EXUDATE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 20036127 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS GIVEN ANTIBIOTIC FOR INFECTION. TOOTH SITES #20 AND #30. SYMPTOMS AS A RESULT OF THE EVENT: PAIN & EXUDATE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 20035383 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO BONE LOSS & INFECTION. TWO WEEKS AFTER PLACEMENT IMPLANT DEVELOPED INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 19962189 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #28 WAS REMOVED DUE TO BONE LOSS & INFECTION. TWO WEEKS AFTER PLACEMENT IMPLANT DEVELOPED INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 19961920 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  2 IMPLANTS PLACED AT SITES #13 & #14, SITE #14 HAD A SINUS LIFT, GRAFTED WITH BONE GRAFT + PNF/PNPC ON IMPLANT PLACEMENT DATE. PT IS A SMOKER AND HAD RECURRENT SINUS INFECTIONS AND FACIAL SWELLING. IMPLANT WAS REMOVED AND SINUS DRAINED. NEW INFECTION ON EMT CONSULTATION - IMPLANT #13 WAS REMOVED SYMPTOMS AS A RESULT OF THE EVENT: PAIN. EDEMA. INFLAMMATION. ABSCESS.

  Patient problems: Sinus Perforation; Unspecified Infection

  MAUDE report 19039022 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 47 WAS REMOVED DUE TO PERI-IMPLANTITIS. AT UNCOVERING OF THE UPPER 4-5 THREADS, THE IMPLANT STOOD APPROXIMATELY 3-4 MM OUT OF THE BONE (WHILE IMPLANT WAS AT BONE LEVEL) AND DOCTOR PERFORMED BONE REGENERATION. THE DOCTOR PERFORMED UNCOVERING AT TOOTH SITE # 47 AND NOTICED A LINGUAL POCKET OF 8 MM, IMPLANT HAD TO BE REMOVED. BONE REGENERATION WAS PERFORMED AT TOOTH SITE # 46.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17492531 ↗
• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF BONE DENSITY ON MESIAL AND DISTAL AT TOOTH SITE # 5. THE IMPLANT WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 17458697 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO INFECTION. SWELLING, INFLAMMATION, ABSCESS AND PAIN ARE REPORTED SYMPTOMS. THE SITE WAS GRAFTED WITH ALLOGRAFT TOGETHER WITH ORIGINAL IMPLANT PLACEMENT AND AFTER EXTRACTION. TOOTH SITE #8 (UNIVERSAL).

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

  MAUDE report 16484817 ↗
• InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS ON TEETH #28 AND #29 WERE REMOVED DUE TO INFECTION.SYMPTOMS OF THE EVENT: ABSCESS AND INFLAMMATION.

  Patient problems: Abscess; Inflammation; Unspecified Infection

  MAUDE report 15670722 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRIMARY STABILITY WAS NOT ACHIEVED WITH THE DENTAL IMPLANT IN TOOTH SITE # 20 (UNIVERSAL). BONE GRAFT WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12590589 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRIMARY STABILITY WAS NOT ACHIEVED WITH THE DENTAL IMPLANT IN TOOTH SITE # 20 (UNIVERSAL). BONE GRAFT WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12590533 ↗
• MalfunctionJun 21, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12032227 ↗
• InjuryApr 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLAINED OF DULL ACHE, IMPLANT AT TOOTH SITE # WAS REMOVED DUE TO SUSPECTED NERVE INVOLVEMENT AND CLINICALLY CONFIRMED INFECTION PRESENT. SITE GRAFTED. PATIENT RETURNING FOR IMPLANT RE-PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION & PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 11637493 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (BNSS410) WAS REMOVED DUE TO INFECTION AT TOOTH LOCATION 12. PAIN WAS ALSO REPORTED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 10583518 ↗
• InjuryJul 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT BUCCAL BONE DEHISCED 7 MM. THE BNSS410 IMPLANT AT TOOTH SITE # 4 WAS REMOVED DUE TO BONE LOSS, SITE GRAFTED.

  Patient problems: No Code Available

  MAUDE report 10278067 ↗