TSX Implants TSX47B11Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00844868045168), received between Apr 3, 2023 and Sep 8, 2026 — classified as 60 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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 66 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that an implant was removed due to a loss of integration and Peri-implantitis. Tooth site 30. Patient suffered from inflammation, pain and swelling.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 50666844 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the implant at tooth site 4 was removed due to infection.

  Patient problems: Unspecified Infection

  MAUDE report 50096308 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #20 WAS REMOVED DUE PERIIMPLANTITIS. REFLECTION OF SOFT TISSUE REVEALED GRANULATION TISSUE ON THE BUCCAL ASPECT OF IMPLANT. IMPLANT ROTATION OCCURRED ATTEMPT TO REMOVE CS. A: PERI-IMPLANTITIS P: LIDOCAINE WITH 1:100K EPI (1 CARP LOCAL), REFLECTED SOFT TISSUE, ATTEMPT TO REMOVE CS, IMPLANT ROTATED. INFORMED PT OF THE INDICATION TO REMOVE, GRAFT, WAIT 6 MONTHS AND RE-ATTEMPT. PT STATED HE UNDERSTOOD AND WOULD LIKE TO RETURN ASAP FOR PROCEDURE. MOD SYMPTOMS: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25473694 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION AND EDEMA.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 25056380 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT IN SITE 8 LACKED INTEGRATION DUE TO PERIIMPLANTITIS. WILL PLACE A NEW IMPLANT AT A LATER DATE. GRAFT PLACED WITH IMPLANT PLACEMENT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24781525 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERIIMPLANTITIS. IMPLANT SITE #4 HAD LOSS OF OSTEOINTEGRATION. THERE WAS ALSO INFECTION PRESENT AND REMOVAL WAS ADAMANT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24758213 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER 46 FAILED DUE TO PERI-IMPLANTITIS AND WAS REMOVED. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 24575020 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24533009 ↗
• MalfunctionFeb 26, 2026Component Missing

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CLINICIAN VIA EMAIL THAT WHEN THE DOCTOR WENT TO OPEN THE CONTAINER, IT WAS EMPTY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24458158 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A SECOND STAGE CLINICAL PROCEDURE EVALUATION, EXPOSURE OF THE COVER SCREW AT IMPLANT #13 WAS ATTEMPTED. A ZIMMER DRIVER WAS USED TO ENGAGE THE COVER SCREW. AN ATTEMPT WAS MADE TO REMOVE THE COVER SCREW AND THE ENTIRE IMPLANT WAS EXPLANTED. NO OSSEAUS ON THE SURFACE OF THE IMPLANT WAS NOTED AND A LACK OF INTEGRATION WAS NOTED. AFTER IMPLANT REMOVAL, THE SITE WAS PATCHED WITH BG AND COVERED TO PRESERVE THE SITE FOR A FUTURE IMPLANT REPLACEMENT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24345385 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 10 WAS REMOVED DUE TO PERI-IMPLANTITIS. DDS ALSO STATES PUS IS COMING FROM FACIAL #10. IMPLANT IS PART OF ALL ON 4....PATIENT SEEN AT REQUEST OF DDS DUE TO THE POSSIBILITY OF UPPER TEMPORARY DENTURE BEING CRACKED. REMOVED IMPLANT AND PLACED NEW IMPLANT THE SAME DAY.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24200401 ↗
• InjuryJan 28, 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 IS PART OF ALL ON 4....PATIENT SEEN AT REQUEST OF DDS DUE TO THE POSSIBILITY OF UPPER TEMPORARY DENTURE BEING CRACKED. REMOVED IMPLANT AND PLACED NEW IMPLANT THE SAME DAY.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24200393 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #22 WAS REMOVED DUE TO PERI-IMPLANTITIS. AT 3 MONTH CHECK X-RAY SHOWS BONE LOSS AROUND IMPLANT. REMOVED IMPLANT AND PLACED BONE GRAFT. NEW IMPLANT PLACED ON (B)(6) 2025.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 24200166 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Erosion; Osteolysis; Unspecified Infection

  MAUDE report 24019326 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO INFECTION. IMPLANT FAILED, THERE WAS A CROWN PLACED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, ABSCESS, INFLAMMATION

  Patient problems: Erosion; Pain; Unspecified Infection

  MAUDE report 24002455 ↗
• InjuryDec 20, 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 INFECTION. SYMPTOMS AS A RESULT OF THE EVENT WERE PAIN, AND INFLAMMATION.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 23858687 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SWELLING AND INFECTION AROUND THE IMPLANT AT TOOTH SITE # 18. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, EDEMA AND INFLAMMATION.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 23731761 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS IN PROSTHESIS AT TOOTH SITES # 43, 44, 45 AND 46 WERE REMOVED DUE TO AN EARLY PERI-IMPLANTITIS ASSOCIATED WITH AN INADEQUATE CEMENT MARGIN. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 23656262 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SEVERE BONE LOSS AROUND IMPLANT AT TOOTH SITE #11. MOBILITY WAS NOTED. THE IMPLANT WAS REPLACED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 23650401 ↗
• 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 INFECTION. NUMBED PATIENT TOOK OUT THE LOOSE IMPLANT AND NEEDS ANTIBIOTICS. PATIENT WILL BE AND RETURNING FOR BONE GRAFT AND IMPLANT, BUT WILL NEED APPROXIMATELY FOUR MONTHS TO HEAL FIRST.

  Patient problems: Unspecified Infection

  MAUDE report 23560295 ↗
• InjuryNov 12, 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. INFECTION NOTICED DURING THE PATIENT'S POST-OPERATIVE EVALUATION. A NEW IMPLANT WILL BE PLACED AT THE SITE ONCE THE AREA HAS HEALED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND INFLAMMATION.

  Patient problems: Erosion; Inflammation; Unspecified Infection

  MAUDE report 23533774 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD POOR GINGIVAL HEALING AROUND THE IMPLANT AT TOOTH SITE #19. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 23464983 ↗
• InjuryNov 3, 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, #7 & #13 WERE REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 23457749 ↗
• InjuryNov 3, 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, #7 & #13 WERE REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 23456478 ↗
• InjuryNov 3, 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, #7 & #13 WERE REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 23456256 ↗