3i T3® DCD® BNPT4313Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00844868028345), received between Jan 8, 2020 and Mar 12, 2025 — classified as 27 injuries.

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 27 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2025Fracture; Fracture

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

  Patient problems: Inflammation

  MAUDE report 21584743 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #15 (FDI) LOST INTEGRATION AND FELL OUT DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21355661 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE IMPLANT AT TOOTH SITE #27 BECAME PAINFUL AND PERI-IMPLANTITIS WAS PRESENT, IMPLANT IS THEN REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 20398522 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN AND SWELLING AROUND THE IMPLANT AT TOOTH LOCATION # 28 AFTER IMPLANT PLACEMENT. THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND SWELLING.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 19633357 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #11 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA, ABSCESS AND INFLAMMATION.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 19322811 ↗
• InjuryApr 10, 2024Separation Failure; Separation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19078069 ↗
• InjuryMar 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SEVERE BONE LOSS AROUND THE IMPLANT AT TOOTH LOCATION #10. THE IMPLANT WAS REMOVED THROUGH DEBRIDEMENT, DETOXIFICATION AND CLOSURE. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 19008364 ↗
• InjuryMar 29, 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 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED. UPON FOLLOW-UP APPOINTMENT, THE IMPLANT WAS CLINICALLY MOBILE AND RADIOGRAPH EXHIBITED SEVERE BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 19007855 ↗
• InjuryNov 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AT IMPLANT TOOTH SITE #7, WITH ASSOCIATED ABSCESS AND INFLAMMATION. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Erosion; Inflammation; Unspecified Infection

  MAUDE report 18207427 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERI-IMPLANTITIS AROUND THE IMPLANT AT TOOTH SITE #15. IMPLANT WAS REMOVED. PATIENT HAD PAIN, ABSCESS AND INFLAMMATION AT TOOTH SITE #15. BONE TYPE IV.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 18144621 ↗
• InjuryOct 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS. TOOTH # 5 . SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis

  MAUDE report 17932620 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #24 FAILED AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOM AS A RESULT OF EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 17324354 ↗
• InjuryMar 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT ON TOOTH SITE #12 WAS REMOVED DUE TO INFECTION. SYMPTOMS OF THE EVENT: ABSCESS.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 16570453 ↗
• InjuryMar 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTION PRESENT. REMOVED IMPLANT. TOOTH # 27.

  Patient problems: Unspecified Infection

  MAUDE report 16472286 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES 12, 13, AND 14 WERE REMOVED DUE TO INFECTION. NOTED PATIENT HAD POST NASAL DRIP AND CONGESTION. SITE WAS GRAFTED WITH ALLOGRAFT TOGETHER WITH IMPLANT PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: POST NASAL DRIP, CONGESTION AND INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 15380358 ↗
• InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS ON TEETH SITES #4, #12, #20, #30, #31 WERE REMOVED DUE TO INFECTION. SYMPTOMS OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 15232394 ↗
• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SINUS INFECTION AFTER PLACEMENT OF AN IMPLANT ON TOOTH SITE #13. IMPLANT WAS REMOVED AND A DEBRIDEMENT OF THE SURGICAL AREA WAS PERFORMED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION, PAIN.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 15084541 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE IMPLANT ON TOOTH SITE #5 WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 14852519 ↗
• InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT ON TOOTH SITE #24 WAS REMOVED BECAUSE OF PERI-IMPLANTITIS. SYMPTOMS OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 14620925 ↗
• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING UNCOVERY AND IMPLANT STABILITY TEST, IMPLANT WERE NOT INTEGRATED TO BONE DUE TO PER-IMPLANTITIS, IMPLANT REMOVED WITH THUMB DRIVER. TOOTH 11.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 14574640 ↗
• InjuryMar 8, 2022Adverse 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 AN INFECTION AT THE SITE. DOCTOR WILL ATTEMPT REPLACEMENT IN THE FUTURE. TOOTH #6.

  Patient problems: Unspecified Infection

  MAUDE report 13690343 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT IT WAS HIS ERROR IN ORIENTING HIMSELF THAT CAUSED PERFORATION OF THE LINGUAL TABLE IN IMMEDIATE IMPLANT PLACEMENT AND IT WAS NECESSARY TO REMOVE THE IMPLANT IN THE CORRECT POSITION, IT DID NOT HAVE STABILITY. THE AFFECTED TOOTH POSITION IS #44. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13505479 ↗
• InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR INDICATED NO PRIMARY STABILITY AT TOOTH SITE # 12. IMPLANT PLACED TO SEVERELY ATROPHIC ALVEOLUS AND UNABLE TO ACHIEVE ADEQUATE TORQUE (SPINNER). THE SITE WAS GRAFTED AND THE PATIENT WAS RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12794270 ↗
• InjurySep 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS PLACED BY GUIDED PLACEMENT AT TOOTH SITE # 8 ON (B)(6) 2021. USED BONE REGENERATIVE MATERIAL (OSSIX VOLUMAX) AS FACIAL BONE JUST AT 2 MM THICK. ABSCESS FIRST NOTED ON (B)(6) 2021 AND ANTIBIOTICS PRESCRIBED. TRIED LAPIP PROCEDURE AT EXPOSURE, PATIENT WAS TO TRAVEL, DECIDED TO REMOVE IMPLANT. PERFORMED SOCKET REGENERATION AT REMOVAL. THE IMPLANT WAS REMOVED DUE TO BEING MOBILE AND PERI IMPLANTITIS. ABSCESS AND INFECTION ARE SYMPTOMS OF THE EVENT.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 12464771 ↗
• InjurySep 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANT SURGERY THE IMPLANT DID NOT ACHIEVE PRIMARY STABILITY AND WAS REMOVED. ANOTHER IMPLANT WOULD BE PLACED.

  Patient problems: No Information

  MAUDE report 10559834 ↗