TSX Implants TSX54B10Recalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 00844868045212), received between May 22, 2023 and Sep 14, 2026 — classified as 82 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 83 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient returned one month postoperatively following implant placement at tooth site 14 with an indirect sinus lift and presented with symptoms of a sinus infection and persistent drainage. The patient completed a course of antibiotics; however, the symptoms persisted. Sinus rinses were recommended, but the patient returned two weeks later with no improvement. Due to the persistent infection, the implant was removed, the maxillary sinus was cleaned, and a larger-diameter implant was placed.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 50754214 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO SINUS PERFORATION AND INFECTION. PATIENT CAME IN FOR POST OP NUMBING ISSUES. PANO X-RAY SHOWED IMPLANT WITH ENCODE WAS IN PATIENT'S SINUS. DOCTOR SURGICALLY REMOVED IMPLANT/ENCODE FROM SINUS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Numbness; Sinus Perforation; Unspecified Infection

  MAUDE report 25407329 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #15 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AT THE IMPLANT SITE AND WAS REMOVED. IMPLANT BECAME MOBILE AND SORE AFTER CROWN PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25173341 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 HAD A LOT OF BONE LOSS AT IMPLANT UNCOVER. THE IMPLANT WAS REMOVED AND A LARGER IMPLANT WAS PLACED.

  Patient problems: Osteolysis

  MAUDE report 25135097 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN EXAMINATION STATING THAT THE IMPLANT AT TOOTH SITE #14 FELT LOOSE AND PAINFUL. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. THE AREA WAS CLEANED AND AN ADDITIONAL APPOINTMENT WAS REQUIRED TO REPLACE THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24966827 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS RESTORED AND BECAME MOBILE AFTER ONE YEAR WITH BONE LOSS AND INFLAMMATION AND WAS REMOVED DUE TO PERI-IMPLANTITIS. AN ADDITIONAL APPOINTMENT WAS REQUIRED TO REPLACE THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24966345 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND A FISTULA AT THE TOOTH SITE #30 AND THE IMPLANT WAS REMOVED DUE TO INFECTION. AN ADDITIONAL APPOINTMENT WAS REQUIRED TO REPLACE THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Abscess; Fistula; Unspecified Infection

  MAUDE report 24865387 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO PERI-IMPLANTITIS AND LOSS OF INTEGRATION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24767137 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN FOR THEIR CHECKUP SHOWING MOBILITY AND INFLAMMATION AROUND THE IMPLANT AT TOOTH SITE #19. THE IMPLANT WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Pain

  MAUDE report 24746336 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO INFECTION. THE PATIENT WAS NOTED TO HAVE EXPERIENCED SEVERE PAIN WHEN PLACING THE ENCODE ON THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 24404985 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED #2 SITE VERTICAL SINUS LIFT WITH IMPLANT PLACEMENT. SINUS PERFORATION AND LACK OF PRIMARY STABILITY. BONE OUTER LIKE 68 MM WITH SPONGY QUALITY.

  Patient problems: Sinus Perforation

  MAUDE report 24308839 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Inflammation; Swelling/ Edema; Unspecified Infection

  MAUDE report 24261756 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT INFECTED, NEEDED TO BE REMOVED. TOOTH NUMBER 14. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24233856 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CALLED COMPLAINING OF SWELLING AROUND THE HEALING ABUTMENT OF THE IMPLANT AT TOOTH SITE #18. A PANOREX TAKEN SHOWED BONE LOSS. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24203761 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS PLACED BY AN ORAL SURGEON WITH THE DOCTOR'S SISTER COMPANY AND A DIFFERENT PROVIDER. THE IMPLANT WAS PLACED IN A POOR POSITION FOR GOOD LONG TERM PROGNOSIS AND ADEQUATE RESTORATION. THE DOCTOR ENDED UP REMOVING THE IMPLANT AND THE ADJACENT DAMAGED TOOTH AT SITE #29. THE TWO SITES WERE BONE GRAFTED AND THE PATIENT WILL RETURN IN 4-5 MONTHS FOR TWO IMPLANTS TO BE PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192617 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT AN UNKNOWN TOOTH SITE WAS REMOVED DUE TO PERI-IMPLANTITIS FOLLOWING A LIMITED EXAM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24086462 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Inflammation; Sinus Perforation; Unspecified Infection

  MAUDE report 23861792 ↗
• 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 #3 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT WERE ABSCESS, AND PAIN.

  Patient problems: Erosion; Pain; Unspecified Infection

  MAUDE report 23858720 ↗
• InjuryDec 5, 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 INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 23732391 ↗
• InjuryNov 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 #14 BECAME MOBILE AFTER CROWN PLACEMENT. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 23604509 ↗
• InjuryNov 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 SITE #19 WAS REMOVED DUE TO BONE LOSS. THE IMPLANT SITE WAS GRAFTED FOLLOWING THE IMPLANT REMOVAL.

  Patient problems: Osteolysis

  MAUDE report 23563256 ↗
• InjuryNov 5, 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: Unspecified Infection

  MAUDE report 23483340 ↗
• InjuryOct 30, 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. IMPLANT WAS MOBILE AT 4 MONTHS POST PLACEMENT, TOOTH # 19. SYMPTOMS AS A RESULT OF THE EVENT WAS LOSS OF INTEGRATION.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23429661 ↗
• InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IN CONSISTENT PAIN AROUND THE IMPLANT AT TOOTH SITE #14. CT SCAN SHOWS A WELL INTEGRATED IMPLANT AND TENTED FLOOR OF THE LEFT MAX AND SINUS CONSISTENT WITH THE SINUS BUMP. THE PATIENT WANTED THE IMPLANT REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Pain

  MAUDE report 22998292 ↗
• InjuryAug 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 #19 WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT SELF EXFOLIATED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 22773506 ↗