TSX Implants TSX37B10Recalls & reported problems

Summary

The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 00844868045045), received between Mar 13, 2023 and Sep 30, 2026 — classified as 100 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (5 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 107 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was observed radiographic bone loss with abcess and the implant was removed due to bone loss and infection.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 50945400 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implants at tooth sites #10 and #11 were removed due to peri-implantitis and infection.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50771252 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implant at tooth site #25 was removed due to peri-implantitis with loss of osseointegration.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50769715 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implant at tooth site #25 was removed due to peri-implantitis.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50769042 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  Discovered : During clinical procedure.Provide detailed description of problem : The implant was removed due to significant bone loss.Patient Impact : No harm to patient.

  Patient problems: Osteolysis

  MAUDE report 50753802 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented with Grade II mobility of an IS bridge. Radiographic examination revealed significant bone loss. Clinical examination showed exposure of the implant threads. The patient was diagnosed with peri-implantitis. It was decided to remove the implants in order to perform guided bone regeneration (GBR) and subsequently place new implants. Tooth sites 11, 13, 22 and 23.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50691167 ↗
• InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 50647740 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT POST OP, THE IMPLANT AT TOOTH SITE #13 WAS REMOVED DUE TO BONE LOSS. LARGER IMPLANT WAS PLACED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 25278282 ↗
• InjuryMay 8, 2026Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A LOSS OF INTEGRATION DUE TO A PERI-IMPLANTITIS AT TOOTH SITE 24. IMPLANT WAS REMOVED. PATIENT WILL RETURN TO COMPLETE THE PROCEDURE. PAIN WAS REPORTED AS A RESULT OF THE EVENT. BONE TYPE: III.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25121127 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN SITE 31 WAS REMOVED DUE TO PERI IMPLANTITIS. PATIENT NOTICED MOBILITY IN CROWN. CBCT SHOWS PERIIMPLANTITIS AROUND ENTIRE IMPLANT, BONE LOSS PRESENT. AREA WAS CLEANED AND GRAFTED. NOTED ABSCESS AND BONE LOSS.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 25117439 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 25 WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 25012634 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 WAS REMOVED DUE TO BONE LOSS AND INFECTION. THE PATIENT'S GENERAL DENTIST NOTICED SUPPURATION AT THE PATIENT'S ROUTINE CLEANING AND BONE LOSS WAS NOTED AFTER RADIOGRAPHIC REVIEW. AN ADDITIONAL APPOINTMENT IS ANTICIPATED TO REPLACE THE IMPLANT ONCE THE BONE GRAFT IS HEALED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24903764 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #7 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24865065 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS AND INFECTION. THE IMPLANT WAS LOOSE AND REMOVED AFTER PROSTHETIC PLACEMENT. NOTED ABSCESS, PAIN

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24831027 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING THE UNCOVERING PROCEDURE OF THE IMPLANT AT TOOTH SITE #13, IT WAS NOTED THAT THE IMPLANT WAS NOT INTEGRATED DUE TO PERI-IMPLANTITIS AND WAS REMOVED. THE BONE SITE WAS GRAFTED AFTER THE IMPLANT REMOVAL. AN ADDITIONAL PROCEDURE WAS ANTICIPATED IN APPROXIMATELY THREE MONTHS TO REPLACE THE IMPLANT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24714895 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS. DURING A FOLLOW UP PATIENT STATED PAIN. CBCT TAKEN, BONE LOSS AT DISTAL ASPECT OF IMPLANT. TOOTH NUMBER 29.SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 24685823 ↗
• InjuryMar 18, 2026Fracture

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 HAD FRACTURED AND WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24630464 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER 12-22 & 14-24 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. PAIN AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24569197 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN SITE 13 WAS REMOVED DUE TO INFECTION. PATIENT PRESENTED AND DRAINING FISTULA. WILL RE-DO IMPLANT IN FUTURE. NOTED ABSCESS AND PAIN.

  Patient problems: Fistula; Pain; Unspecified Infection

  MAUDE report 24498116 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT NOTICED A COUPLE MONTHS AFTER RESTORATION THAT HIS IMPLANT WAS LOOSE. IMPLANT WAS THEN SURGICALLY REMOVED DUE TO PERI-IMPLANTITIS. TOOTH NUMBER 13.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24484339 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #20 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE IMPLANT DID NOT INTEGRATE DUE TO FAILED OSSEOINTEGRATION. AN ADDITIONAL APPOINTMENT WAS REQUIRED FOR RE-IMPLANTATION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24461742 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Abscess; Fistula; Unspecified Infection

  MAUDE report 24441306 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SORE AROUND THE IMPLANT AT TOOTH SITE #20. THE IMPLANT WAS REMOVED DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 24392878 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Osteolysis

  MAUDE report 24347182 ↗
• MalfunctionFeb 3, 2026Component Missing

  IT WAS REPORTED THAT THE IMPLANT VIAL ARRIVED EMPTY. THE BOX WAS SEALED AND THEY FOUND THAT THE IMPLANT WAS MISSING WHEN IT WAS OPENED. IT WAS DISCOVERED DURING THE PROCEDURE AND ANOTHER IMPLANT WAS ABLE TO BE PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250699 ↗