TSX Implants TSX41B11Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 00844868045106), received between Apr 6, 2023 and Sep 15, 2026 — classified as 66 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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 68 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implants at tooth sites #10 and #11 were removed due to peri-implantitis and infection.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50772658 ↗
• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that there was not enough bone in area as when the implant was placed in site #14. Implant was removed due to bone loss.Will returned to place implant once bone fills in.

  Patient problems: Osteolysis

  MAUDE report 50299669 ↗
• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the implants were removed due to infection.. Patient suffered inflammation.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 50298119 ↗
• InjuryJul 28, 2026Fracture

  It was reported that an implant was removed due to a fracture resulting from trauma.Patient suffered from inflammation.

  Patient problems: Inflammation

  MAUDE report 50054458 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that implant at tooth site # 35 was removed due to a bone loss.

  Patient problems: Osteolysis

  MAUDE report 50034824 ↗
• InjuryJun 12, 2026Adverse 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: PAIN, EDEMA, AND INFLAMMATION.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 25490654 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT FAILED AND WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, INFLAMMATION, PAIN AND SWELLING.

  Patient problems: Abscess; Inflammation; Unspecified Infection

  MAUDE report 25462325 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING A LOT OF PAIN AROUND THE IMPLANT AT TOOTH SITE #12 AND WANTED IT TAKEN OUT. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND SWELLING.

  Patient problems: Inflammation; Pain; Swelling/ Edema

  MAUDE report 25206726 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 WAS REMOVED DUE TO SINUS PERFORATION. PT WAS HAVING PAIN WHERE THE IMPLANT WAS PLACED- TOO CLOSE TO SINUS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN

  Patient problems: Pain; Sinus Perforation

  MAUDE report 25175331 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT UNCOVER APPOINTMENT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS AND LOSS OF INTEGRATION. TOOTH NUMBER: 20.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25124696 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 22 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25012700 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #9 WAS REMOVED DUE TO PERI-IMPLANTITIS. AN ADDITIONAL APPOINTMENT WAS REQUIRED TO REPLACE THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24899948 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN SITE 27 HAD BONE LOSS AND INFLAMMATION AROUND IT. IMPLANT WAS REMOVED AND REPLACED WITH A TSX41B11. NOTED INFLAMMATION.

  Patient problems: Inflammation; Osteolysis

  MAUDE report 24866274 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS PLACED AT TOOTH SITE #6 AS AN IMMEDIATE WITH GRAFT AND MEMBRANE. AT THE POST-OPERATIVE APPOINTMENT, THERE WAS SWELLING PRESENT AND A FOLLOW UP CT SCAN NOTED BONE LOSS AROUND THE BUCCAL PLATE. THE IMPLANT WAS REMOVED AND GRAFT WAS REPLACED.

  Patient problems: Osteolysis; Swelling/ Edema

  MAUDE report 24866119 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN SITE 4 LACKED INTEGRATION DUE TO PERI-IMPLANTITIS. WILL PLACE A NEW IMPLANT AT A LATER DATE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24768117 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT PRESENTED TO HAVE IMPLANT #3 EVALUATED DUE TO DISCOMFORT AND IT WAS DETERMINED PERI-IMPLANTITIS. IMPLANT #3 WILL BE REPLACED ONCE THE BONE GRAFT IS HEALED. SYMPTOMS AS A RESULT OF THE EVENT: DISCOMFORT, ABSCESS, INFLAMMATION & PAIN

  Patient problems: Discomfort; Osteolysis; Unspecified Infection

  MAUDE report 24634589 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITE # 12,22,14, 24 WERE REMOVED DUE TO A PERI-IMPLANTITIS. PATIENT SUFFERED FROM PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24597645 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED ABOUT A MONTH AFTER SURGERY WITH INFECTION AROUND THE IMPLANT AT TOOTH SITE #19. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND SWELLING.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 24594313 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITE # 12,22,14, 24 WERE REMOVED DUE TO A PERI-IMPLANTITIS. PATIENT SUFFERED FROM PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24589849 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER 12-22 & 14-24 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. PAIN AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24569058 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITES #15 AND #24 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24560745 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT UN-COVERY, THE IMPLANT AT TOOTH SITE #8 WAS DISCOVERED TO BE INFECTED. THE IMPLANT WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 24524396 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT IN CLINIC TO GET REVISION SURGERY DUE TO BONE BEING TO HIGH IN LOWER ARCH TO GET LOWER DENTURE LUBRICATED. (DUE TO SUPRAERUPTION OF THE MANDIBULAR ARCH AND ASSOCIATED BONE IRREGULARITIES, IMPLANT WAS REMOVED. A MANDIBULAR ARCH ALVEOLECTOMY WAS PERFORMED, AND NEW IMPLANT WAS PLACED. SITE AFFECTED #27. WILL RETURN IN 5 MONTHS TO TEST NEW IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378012 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT IN CLINIC TO GET REVISION SURGERY DUE TO BONE BEING TO HIGH IN LOWER ARCH TO GET LOWER DENTURE LUBRICATED. (DUE TO SUPERERUPTION OF THE MANDIBULAR ARCH AND ASSOCIATED BONE IRREGULARITIES, ALL FOUR IMPLANTS WERE REMOVED. A MANDIBULAR ARCH ALVEOLECTOMY WAS PERFORMED, AND NEW IMPLANTS WERE PLACED AT EACH SITE. SITE AFFECTED WAS #22. WILL RETURN IN 5 MONTHS TO TEST NEW IMPLANT. NOTED HISTORY OF BRUXISM BONE TYPE 2. ALLOGRAFT PLACED (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376192 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS. BONE LOSS REPORTED. FAILED IMPLANT. TOOTH NUMBER 6. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 24308530 ↗