TSX Implants TSX47B8Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00844868045205), received between Aug 10, 2023 and Sep 15, 2026 — classified as 74 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 74 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implant at tooth site #14 was removed due to peri-implantitis. The patient experienced pain and swelling.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 50768852 ↗
• InjurySep 10, 2026Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  It was reported that the implant at tooth site #14 developed fibrous encapsulation and became mobile. Doctor reported sinus infection and perforated sinus with loss of integration. The patient also experienced pain and abscess. The implant was subsequently removed.

  Patient problems: Abscess; Osteolysis; Sinus Perforation

  MAUDE report 50713877 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient came to the clinic with discomfort in the area and suppuration due to an infection. Doctor decided to remove the implants. Tooth sites 14 & 16.

  Patient problems: Discomfort; Purulent Discharge; Unspecified Infection

  MAUDE report 50668976 ↗
• InjuryAug 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the implant at tooth site 14 was tender to palpation and mobile. Implant was removed due to peri-implantitis. Noted Pain and inflammation.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 50263979 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO MEDICAL BONE LOSS AND INFECTION. TOOTH NUMBER 30. AA. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 25474445 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN SITE 3 WAS LOOSE AND HAS BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 25247016 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 36 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 25174110 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT CHECKUP, THE PATIENT HAD PAIN AROUND THE IMPLANT AT TOOTH SITE #14. THE IMPLANT WAS ALSO MOBILE 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 25170407 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24865442 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 LACKED INTEGRATION DUE TO PERI-IMPLANTITIS. WILL PLACE A NEW IMPLANT AT A LATER DATE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24821413 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO BONE LOSS AND INFECTION. THIS WAS DISCOVERED DURING A PATIENT EVALUATION DUE TO PAIN AND SWELLING. IT WAS NOTED THAT THERE WAS 5MM OF PROVING DEPTHS WITH PURULENCE IN THE SULCUS. X-RAY IMAGING CONFIRMED BONE LOSS DOWN TO 50% OF THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 24808908 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN SITE 20 LACKED INTEGRATION DUE TO PERIIMPLANTITIS. WILL PLACE A NEW IMPLANT AT A LATER DATE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24776126 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis

  MAUDE report 24737563 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEW MONTHS AFTER THE CROWN WAS INSERTED, THE PATIENT RETURNED TO THE OFFICE WITH THE IMPLANT AND CROWN AT TOOTH SITE # 14 IN HAND.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24734633 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis

  MAUDE report 24711899 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 24661297 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI IMPLANTITIS. DURING UNCOVER TISSUE AT SITE #31 TISSUE WAS INFLAMED. REMOVED IMPLANT, GRAFTED AND ADDED BONE TO SITE. WILL ACCEPT REPLACEMENT WHEN HEALED. NOTED INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24625938 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 24507736 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 17 WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN WHEN CHEWING AND REMOVAL OF A MOBILE IMPLANT. ABSCESS REPORTED AS A RESULT OF THE EVENT. A BONE GRAFT WAS NECESSARY TO PREVENT PERMANENT DAMAGE.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24496791 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED ABOUT PAIN IN THE AREA AROUND THE IMPLANT AT TOOTH SITE #14. THE IMPLANT WAS REMOVED DUE TO BONE LOSS AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24442917 ↗
• InjuryFeb 19, 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 LOST INTEGRATION 3 WEEKS AFTER PLACEMENT SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24393987 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH BONE LOSS ON THE IMPLANT AT TOOTH SITE #31 AND REQUESTED TO HAVE IT REMOVED. THE SEVERE BONE LOSS WAS NOTED ON THE MESIAL ASPECT. THE IMPLANT WAS REMOVED AND SITE PRESERVATION WAS PERFORMED. AN ADDITIONAL APPOINTMENT WAS REQUIRED TO REPLACE THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND EDEMA.

  Patient problems: Osteolysis; Pain; Swelling/ Edema

  MAUDE report 24338746 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis; Pain; Swelling/ Edema

  MAUDE report 24261825 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #29 & #30 DEVELOPED PERI-IMPLANTITIS AFTER BEING RESTORED. THE IMPLANTS WERE REMOVED & THE SITES GRAFTED FOR FUTURE IMPLANT PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN & INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24192372 ↗
• InjuryJan 14, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 23 AND 26 WERE LOOSE, EASY TO UNSCREW AND REMOVED DUE TO INFECTION AND ALLERGIC REACTION.

  Patient problems: Hypersensitivity/Allergic reaction; Unspecified Infection

  MAUDE report 24065561 ↗