TSX Implants TSX6B11Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00844868045281), received between Apr 30, 2024 and Aug 17, 2026 — classified as 18 injuries, 1 malfunction.

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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented for implant removal due to bone loss around the implant, which was identified on X-ray during the clinical procedure. No harm to the patient was reported.

  Patient problems: Osteolysis

  MAUDE report 50273468 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT THREE (3) WEEKS POST OP, THE PATIENT COMPLAINED OF PAIN AROUND THE IMPLANT AT TOOTH SITE #19. GRANULATION TISSUE HAD ALSO GROWN OVER THE ENCODE. THE TISSUE WAS REMOVED AND A CAUTERY STICK WAS USED. THE PATIENT WAS PLACED ON PCN 500MGS 28 FOR ONE (1) WEEK. THE PATIENT RETURNED IN ONE (1) WEEK STILL HAVING PAIN AND GRANULATION TISSUE GROWING OVER THE ENCODE AGAIN. THE PATIENT RETURNED FOR TISSUE TRIM AND FINAL CHECK AND AT THAT APPOINTMENT, THE IMPLANT WAS FOUND TO BE MOBILE. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS, AND AN IMMEDIATE IMPLANT WAS PLACED THAT DAY. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25153858 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED FIVE (5) DAYS POS- OP COMPLAINING OF PAIN AROUND THE IMPLANT AT TOOTH SITE #30. AN EXAM SHOWED TISSUES TO BE PINK AND HEALTHY. THE PATIENT RETURNED ONE (1) WEEK LATER FEELING MUCH BETTER. THE PATIENT RETURNED ONE (1) MONTH LATER FOR A SCHEDULED RE-EVALUATION AND HAD NO COMPLAINTS. THE IMPLANT WAS SOLID. AT THREE (3) MONTHS POST IMPLANT PLACEMENT, THE PATIENT WAS SEEN FOR THE FINAL CHECK AND WAS HEALING WELL AND READY TO RESTORE. THE PATIENT RETURNED ONE (1) MONTH LATER AND STATED HAVING NO PAIN UNTIL THE DDS USED A RATCHET ON THE IMPLANT. THE DDS FOUND THE IMPLANT TO BE MOBILE AND REMOVED IT WITH FINGER PRESSURE. INFECTED TISSUE WAS FOUND UPON REMOVAL. THE AREA WAS DEBRIDED AND PUROS GRAFT WAS PLACED. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25153624 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Discomfort; Pain

  MAUDE report 24597456 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN COMPLAINING OF PAIN AT THE IMPLANT AT TOOTH SITE #18. PATIENT ALSO HAD SIGNIFICANT SWELLING AT SITE. PATIENT HAD TO BE SEDATED TO REMOVE THE IMPLANT. AN INCISION WAS MADE AND THE SITE WAS DEBRIDED WITH DRAIN PLACEMENT AT SITE. PATIENT WILL RETURN IN A FEW MONTHS FROM IMPLANT PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION, ABSCESS.

  Patient problems: Abscess; Inflammation; Unspecified Infection

  MAUDE report 24472401 ↗
• InjuryDec 22, 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: Unspecified Infection

  MAUDE report 23866416 ↗
• InjuryNov 3, 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 #30 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT WAS SEEN SIXTEEN DAYS POST-IMPLANTATION PROCEDURE DUE TO PAIN. NOTED SWELLING ON BUCCAL WITH SMALL AMOUNT OF EXUDATE. TENDER WHEN CHECKING ENCODE. IMPLANT WAS REMOVED EASILY. NO APPOINTMENT WITH THE PATIENT HAS BEEN CONFIRMED TO REPLACE THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND SWELLING.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 23457757 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REPORTED TO THE CLINIC COMPLAINING OF PAIN AT THE LOWER RIGHT IMPLANT. UPON INSPECTION, THE IMPLANT AT TOOTH SITE #30 WAS MOBILE. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. THE AREA WAS DEBRIDED AND GRAFTED. WILL ATTEMPT TO REPLACE THE IMPLANT IN 4-6 MONTHS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 23438429 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT LOST INTEGRATION AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 23437864 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED COMPLAINING ABOUT INCREASING TENDERNESS AT SITE #30. AN INCISION WAS MADE TO DRAIN THE PUS. THE IMPLANT WAS REMOVED AND ANOTHER APPOINTMENT WAS REQUIRED TO REPLACE THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 23304791 ↗
• InjurySep 3, 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 SINUS PERFORATION. TOOTH LOCATION IS UNKNOWN.

  Patient problems: Sinus Perforation

  MAUDE report 22951144 ↗
• InjuryAug 7, 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 #19 WAS REMOVED DUE TO BONE LOSS. THERE WAS BONE LOSS ON THE FACIAL SIDE THAT EXPOSED THE TOP OF THE IMPLANT.

  Patient problems: Osteolysis

  MAUDE report 22736660 ↗
• InjuryJun 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 #30 WAS NO LONGER STABLE DUE TO BONE LOSS. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION & PAIN.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22166951 ↗
• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS BONE LOSS AROUND THE IMPLANT AT TOOTH SITE #5. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION & PAIN.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22166537 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME TO THE OFFICE FOR A TORQUE TEST BEFORE GOING TO THE GENERAL DENTIST. THE DOCTOR REMOVED THE HEALING ABUTMENT, THEN DID A TORQUE TEST HOWEVER, THE IMPLANT WAS MOBILE. THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO PERI-IMPLANTITIS. ANOTHER IMPLANT WAS PLACED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 21446867 ↗
• 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 LOCATION #30 WAS REMOVED DUE TO BONE LOSS AND INFECTION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20199711 ↗
• 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 LOCATION #30 WAS REMOVED DUE TO BONE LOSS AND INFECTION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20199474 ↗
• MalfunctionSep 10, 2024Component Missing; Component Missing

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185710 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CAME BACK 3 DAYS LATER WITH GRAFT LOSS AND SWELLING. IMPLANT WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Pain

  MAUDE report 19217491 ↗