TSX Implants TSX37B8Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00844868045083), received between May 15, 2023 and Aug 22, 2026 — classified as 36 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2026Adverse Event Without Identified Device or Use Problem

  The doctor reports that the dental implant failed due to peri-implantitis. Implant was removed. Tooth site 16. The doctor reports in the PER that the procedure was not concluded by placing another implant. The doctor reported : Inflammation.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 50385745 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported bone loss present around implants 9 and 7.

  Patient problems: Osteolysis

  MAUDE report 50139977 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that an implant was removed due to a peri-implantitis. Tooth site 13.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50017611 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CALLED AND COMPLAINED OF PAIN AROUND THE IMPLANT AT TOOTH SITE #20. THE IMPLANT WAS FOUND TO BE MOBILE AND WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION & PAIN.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 25170903 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO BONE LOSS. THE PATIENT REPORTED PAIN. BONE LOSS WAS NOTED AROUND THE IMPLANT. AN ADDITIONAL APPOINTMENT IS ANTICIPATED TO REPLACE THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 24802591 ↗
• MalfunctionMar 30, 2026Mechanical Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24728393 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT WAS REPORTED TO HAVE BEEN PAINFUL AND MOBILE FOUR MONTHS POST-PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24446571 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24429906 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #4 AND #5 WAS REMOVED DUE TO PERI-IMPLANTITIS. THIS WAS NOTED AFTER LIMITED EXAMINATION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24203305 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #4 AND #5 WAS REMOVED DUE TO PERI-IMPLANTITIS. THIS WAS NOTED AFTER LIMITED EXAMINATION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24203193 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN EXPLORATORY PROCEDURE WAS DONE TO DETERMINE STABILITY OF THE IMPLANT. AFTER EVALUATION, THE IMPLANT CAME OUT WHILE REMOVING THE COVER SCREW DUE TO INFECTION. TOOTH LOCATION WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 24068773 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN EXPLORATORY PROCEDURE WAS CONDUCTED TO DETERMINE THE STABILITY OF THE IMPLANT. AFTER THE EVALUATION, THE IMPLANT CAME OUT WHILE REMOVING THE COVER SCREW.

  Patient problems: Unspecified Infection

  MAUDE report 24060622 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED FOR FOLLOW-UP WITH A COMPLAINT OF INFLAMMATION AND DISCOMFORT AROUND THE IMPLANT AT TOOTH SITE #27. THIS WAS NOTED TO HAVE BEEN APPROXIMATELY ONE MONTH POST-PLACEMENT. THE IMPLANT WAS REMOVED AND THE AREA GRAFTED IN ANTICIPATION OF AN IMPLANT REPLACEMENT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24060405 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CAME FOR HYGIENE, HAD DISCOMFORT ON GUMS SINCE SEVERAL DAYS, BRIDGE UNSCREWED AND IMPLANT CAME OUT DUE TO BONE LOSS. CURETTAGE PERFORMED AND WAIT FOR NEW IMPLANT PLACEMENT. TOOTH #35.

  Patient problems: Discomfort; Osteolysis

  MAUDE report 24052890 ↗
• InjuryDec 11, 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 #14 WAS REMOVED DUE TO PERI-IMPLANTITIS WITH ABSCESS AND INFLAMMATION. UPON THREE (3) MONTHS OF INTEGRATION, PATIENT HAD PAIN. DOCTOR ALSO INDICATED POSSIBLE FIBROSIS.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 23783655 ↗
• InjuryNov 25, 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 #44, #45, AND #46 WERE REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Osteolysis; Pain

  MAUDE report 23647137 ↗
• InjuryNov 25, 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 #44, #45, AND #46 WERE REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.

  Patient problems: Inflammation; Osteolysis; Pain

  MAUDE report 23647035 ↗
• InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 23343288 ↗
• InjuryOct 15, 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 PERI-IMPLANTITIS. TOOTH SITE #35. SYMPTOM REPORTED ON THE PATIENT WAS INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 23302333 ↗
• InjurySep 12, 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 BONE LOSS. PATIENT HERE FOR FINAL X-RAY ON IMPLANT. PATIENT HAS A 5MM PROBING DEPTH AND BLEEDING UPON PROBING ALONG THE MESIAL, THERE 15A 4MM PROBING DEPTH ON THE MID-BUCCAL, X-RAY SHOWS BONE LOSS CONSISTENT WITH FAILURE. TOOTH #4.

  Patient problems: Osteolysis

  MAUDE report 23043303 ↗
• InjuryAug 11, 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 #4 AND #11 WERE REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22777910 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #15 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22202428 ↗
• InjuryMay 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN EXAM THIN BONE WAS PRESENTED IN THE AREA OF TOOTH SITES 11-12. THERE WAS ALSO THIN BONE ON THE LABIAL AND A SMALL CRACK ON THE SIDE OF THE IMPLANT AT TOOTH SITE #11. THE IMPLANT WAS REMOVED DUE TO A FRACTURE AND BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 22070792 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A LOSS OF INTEGRATION DUE TO A PERIIMPLANTITIS AT TOOTH SITE: #36 - #46. BOTH IMPLANTS WERE REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22070532 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PERI-IMPLANTITIS AT TOOTH SITE 37. THE PROCESS WAS NOT COMPLETED WITH ANOTHER IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21958685 ↗