TSX Implants TSX31B11Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00844868045007), received between Sep 11, 2023 and Sep 8, 2026 — classified as 31 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 32 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that an implant was removed due to a Peri-implantitis. Tooth site 7.Patient suffered from abscess, edema, inflammation and swelling.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 50667623 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO (2) IMPLANTS BECAME INFECTED FAILING TO INTEGRATE. THE IMPLANTS WERE REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION. TOOTH LOCATIONS WERE NOT PROVIDED.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 25285361 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IT WAS NOTICED THAT THE IMPLANT HAD FAILED AT STAGE 2. THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 25240586 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. DISCOVERED DURING CLINICAL PROCEDURE, FAILED IMPLANT @ STAGE 2. WILL RETURN FOR ANOTHER IMPLANT IN FUTURE. SYMPTOMS / PATIENT IMPACT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 25115998 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #7 FAILED AT STAGE 2 AND WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 25110861 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS AT TOOTH SITE # 35+34 LOST INTEGRATION DUE TO PERI-IMPLANTITIS. IMPLANTS WERE REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24922716 ↗
• MalfunctionMar 25, 2026Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690419 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT AT TOOTH SITE 42 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24588047 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN COMPLAINING OF PAIN FROM THE AREA AROUND THE IMPLANT AT TOOTH SITE #24. PAIN AND BONE LOSS WERE NOTED AROUND THE IMPLANT. THE PATIENT CAME BACK TO HAVE THE IMPLANT REMOVED DUE TO PERI-IMPLANTITIS. THE SITE WAS CLEANED AND GRAFTED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24462023 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 24161319 ↗
• InjuryDec 3, 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: Osteolysis; Unspecified Infection

  MAUDE report 23708541 ↗
• InjuryNov 21, 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 #13 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23616618 ↗
• InjuryOct 31, 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; Unspecified Infection

  MAUDE report 23438294 ↗
• InjurySep 8, 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 #26 FAILED TO OSTEOINTEGRATE, THE PATIENT RETURNED WITH PUS AROUND THE IMPLANT. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22991079 ↗
• InjuryAug 19, 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 #6 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, INFLAMMATION AND PAIN.

  Patient problems: Erosion; Inflammation; Unspecified Infection

  MAUDE report 22837768 ↗
• InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TEETH #6 AND #8 WERE EXTRACTED WITH IMMEDIATE GUIDED IMPLANT PLACEMENT USING IMPLANT CONCIERGE. THE #6 IMPLANT WAS PLACED TOO FACIAL AND THE PATIENT EXPERIENCED DISCOMFORT FOR 3-4 WEEKS. THE IMPLANT WAS REMOVED DUE TO PAIN AND A NEW IMPLANT WAS REPOSITIONED MORE PALATAL. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION & PAIN.

  Patient problems: Discomfort; Inflammation; Pain

  MAUDE report 22152710 ↗
• InjuryMay 24, 2025Adverse 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 PERI-IMPLANTITIS. TOOTH # 10. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22082098 ↗
• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PURULENCE WAS PRESENT AROUND THE IMPLANT AT TOOTH SITE #27. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, INFLAMMATION, PAIN & SWELLING.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 21265140 ↗
• InjuryJan 13, 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 #23 WAS REMOVED DUE TO INFECTION. IMPLANT WAS LOOSE.

  Patient problems: Unspecified Infection

  MAUDE report 21137647 ↗
• InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 22 AND 15 WERE REMOVED DUE TO PERI-IMPLANTITIS WITH INFLAMMATION. AFTER SECOND STAGE WHILE TAKING MEASURES PATIENT REFERRED PAIN AFTER PLACING ABUTMENT AND IMPLANT ROTATED.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21102026 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERI-IMPLANTITIS, TOOTH #7. PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. ADDITIONAL APPOINTMENT REQUIRED: YES, FOLLOW UP. SYMPTOMS AS A RESULT OF THE EVENT: LOSS OF INTEGRATION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21034675 ↗
• InjuryNov 20, 2024Adverse 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: Osteolysis; Pain; Unspecified Infection

  MAUDE report 20740810 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ABOUT TO HAVE A CROWN PLACED WHEN THE DENTIST NOTICED A FISTULA ON THE FACIAL. UPON EVALUATION, THE IMPLANT AT TOOTH SITE # 27 HAD GRANULATION TISSUE. THE IMPLANT WAS REMOVED DUE TO BONE LOSS AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 20577999 ↗
• InjurySep 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 #10 BACKED OUT WHILE ATTEMPTING TO REMOVE HEALING ABUTMENT, DURING A CLINICAL PROCEDURE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 20202242 ↗
• InjurySep 11, 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 # 10 PLACED ON (B)(6) 2024, HAD NO ISSUES POST-OP. LATER, PATIENT REPORTED THAT THE IMPLANT CAME OUT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN. EDEMA.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 20194213 ↗