TSX Implants TSX41B16Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00844868045120), received between Oct 19, 2023 and Apr 17, 2026 — classified as 10 injuries.

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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 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 IS ANTICIPATED TO PLACE A BRIDGE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24911917 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO PERI-IMPLANTITIS. AN ADDITIONAL APPOINTMENT WAS REQUIRED TO REPLACE THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 24911415 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #5 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 24865025 ↗
• InjuryFeb 23, 2026Adverse 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 24417787 ↗
• InjuryFeb 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 24417013 ↗
• InjuryDec 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #14, #23, #34, AND #45 WERE REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 23797597 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #6, #8, #10 AND #13 WERE REMOVED DUE TO PERI-IMPLANTITIS. PATIENT HAD SEVERAL RECHECK APPOINTMENTS TO HAVE DEBRIDEMENT DONE. PATIENT WANTED ALL IMPLANTS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 23759348 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH #43 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20564900 ↗
• InjuryOct 18, 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: Fistula; Osteolysis

  MAUDE report 20480969 ↗
• InjuryOct 19, 2023Component Missing; Component Missing

  THE SALES REP REPORTED THAT WHEN THE CLINICIAN OPENED ONE OF THE IMPLANTS, THEY FOUND THE IMPLANT, MOUNT AND COVER SCREW WERE MISSING. PRODUCT WAS SEALED WHEN OPENED. THE SURGICAL PROTOCOL HAD TO BE CHANGED BUT AN IMPLANT WILL BE PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17966786 ↗