TSX Implants TSX6B8Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00844868045328), received between Apr 21, 2024 and Aug 18, 2026 — classified as 14 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the site had loss of stability, infection, and bone loss, with associated pain and edema therefore implant was removed.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50302886 ↗
• MalfunctionMar 30, 2026Peeled/Delaminated; Device Damaged by Another Device

  DOCTOR REPORTED THAT IMPLANT EDGE WAS DAMAGED DURING PLACEMENT. ANOTHER IMPLANT WAS PLACED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727475 ↗
• InjuryMar 20, 2026Unintended Movement

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 LOOSENED. THE PRODUCT WAS A SCREW RETAINED RESTORATION ON THE SAME IMPLANT, WHICH IS BEING RETURNED TO AID IN THE INVESTIGATION. AS THIS CASE HAD BEEN INHERITED FROM ANOTHER DENTAL OFFICE, NO ADDITIONAL INFORMATION WAS PROVIDED CONCERNING THE PREVIOUS RESTORATIONS OR ABOUT THE CROWN OR ABUTMENT DETAILS. THE PATIENT WILL RETURN FOR AN IMPLANT REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24653093 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis; Pain

  MAUDE report 24524563 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT LOSS INTEGRATION 4 MONTHS POST PLACEMENT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24401472 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 FAILED AND WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 24304612 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. PATIENT HAD PAIN, SWELLING AND INFECTION AFTER FIRST PLACEMENT. TOOTH SITE: 18. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION PAIN AND ABSCESS.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 23959194 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO IMPLANTS HAD FAILED AT THE PATIENT'S SURGICAL RELEASE AND WERE REMOVED. NOT SURE WHY THEY FAILED AND TOOTH LOCATIONS ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525920 ↗
• InjuryAug 12, 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 #15 WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT MOBILITY WAS NOTED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22787305 ↗
• InjuryJul 14, 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 #3 FAILED AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA AND INFLAMMATION.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 22495421 ↗
• InjuryJul 9, 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 #15 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 22456767 ↗
• MalfunctionApr 17, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED IMPLANT STRIPPED IN THE INTERNAL HEX DURING PLACEMENT WAS ABLE TO COMPLETE PLACEMENT BY HAND WRENCHING OR WITH MOTOR. THE IMPLANT WAS REMOVED AND REPLACED IN THE SAME SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860468 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Pain; Sinus Perforation

  MAUDE report 21854963 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERIIMPLANTITIS. PATIENT CAME IN CLINIC TO EVALUATE SITE # 3 AFTER HIS IMPLANT CAME OUT AT HOME.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21617651 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME TO TEST HER IMPLANT AND IT WAS MOBILE. DOCTOR REMOVED IT AND PLACED BONE. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 20150133 ↗
• InjuryApr 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEEN AT GENERAL DDS FOR HYGIENE, THEY FOUND EXUDATE AROUND THE IMPLANT. AT EXAM, THE TISSUE AROUND THE IMPLANT WERE PUFFY WITH 5MM POCKETS AND BLEEDING. IMPLANT WAS TENDER TO PERCUSSION. THE PATIENT EXPERIENCED PERI-IMPLANTITIS AT IMPLANT TOOTH SITE #31, WITH ASSOCIATED PAIN AND INFLAMMATION. THEREFORE, THE IMPLANT WAS UNSCREWED WITH A HAND WRENCH, REMOVED. THE AREA WAS CLEANED AND RE-GRAFTED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19149936 ↗