TSX Implants TSX31B8Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00844868045038), received between Mar 15, 2024 and Dec 20, 2025 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 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 #5 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 23858522 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN ANNUAL FOLLOW-UP APPOINTMENT AND IMPLANT EXPOSURE WAS EVIDENT AROUND THE IMPLANTS AT (FDI) TOOTH SITES #31 AND #32. AN X-RAY WAS TAKEN AND SIGNIFICANT BONE LOSS WAS FOUND. THE IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23708842 ↗
• 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 23708745 ↗
• 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 23708633 ↗
• InjuryNov 4, 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 #45 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23467995 ↗
• InjuryOct 4, 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 15 WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN, INFLAMMATION AND ABSCESS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 20366908 ↗
• MalfunctionSep 26, 2024Unsealed Device Packaging; Unsealed Device Packaging

  DOCTOR REPORTED THAT IN THE LAST ORDER THEY RECEIVED THERE WERE SOME IMPLANTS WITH A CRACKED CAP. DOCTOR NOTICED AT THE TIME OF SURGERY AND IMPLANTS WERE CHANGED BY DISTRIBUTOR FOR NEW ONES. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20307951 ↗
• MalfunctionSep 26, 2024Unsealed Device Packaging; Unsealed Device Packaging

  DOCTOR REPORTED THAT IN THE LAST ORDER THEY RECEIVED THERE WERE SOME IMPLANTS WITH A CRACKED CAP. DOCTOR NOTICED AT THE TIME OF SURGERY AND IMPLANTS WERE CHANGED BY DISTRIBUTOR FOR NEW ONES. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20307856 ↗
• InjuryMar 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 SITE #11 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 18915110 ↗