TSX Implants TSX54B8Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00844868045267), received between Oct 12, 2023 and May 5, 2026 — classified as 31 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (1 report).

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 31 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO BONE LOSS. DURING FOLLOW UP APPOINTMENT NOTICED MOBILITY OF IMPLANT. REMOVED IMPLANT AND WILL GIVE TIME TO HEAL, WILL HAVE FOLLOW UP APPOINTMENT FOR NEW IMPLANT PLACEMENT.

  Patient problems: Osteolysis

  MAUDE report 25081194 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #18 WAS REMOVED DUE TO PERI-IMPLANTITIS. A DENTAL IMPLANT SITE #18 WAS PLACED USING GUIDED PROTOCOL AND FLAPLESS ENTRY METHOD. 5 MONTHS OF HEALING ALLOWED AND INTEGRATION ACHIEVED. SCREW RETAINED CROWN WAS INSERTED AND PT STARTED USING TOOTH WITH NO PROBLEMS. ABOUT 15 MONTHS LATER, PT PRESENTED WITH PAIN AND CBCT SHOWED BONE LOSS AROUND IMPLANT WITH IMPLANT BODY LOOSE. IMPLANT WAS REMOVED AND SITE CURETTAGE/GRAFTED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN & EDEMA.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 24758555 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS. PATIENT CAME IN FOR CHECK UP DUE TO INSTABILITY, BONE LOSS WAS PRESENT. TOOTH NUMBER: 14.

  Patient problems: Osteolysis

  MAUDE report 24747820 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 23991450 ↗
• InjuryDec 22, 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. PATIENT REPORTED NOTICING HER IMPLANT WAS LOOSE RECENTLY. UPON EXAM AND RADIOGRAPH INTERPRETATION, NOTED RADIOLUCENCY AROUND IMPLANT BODY. PATIENT DID NOT HAVE OCCLUSAL CONTACTS WITH THE OPPOSING DENTITION. PRESCRIBED XANAX PRIOR TO IMPLANT REMOVAL PER PATIENT REQUEST. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND SWELLING.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 23866645 ↗
• InjuryDec 17, 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 #30 FAILED ONE (1) YEAR AFTER LOADING AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, EDEMA & INFLAMMATION.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 23829625 ↗
• InjuryNov 3, 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 BUCCAL BONE FRACTURE THAT LED TO LACK OF PRIMARY STABILITY. SURGICAL INTERVENTION WAS NOT REQUIRED TO PREVENT PERMANENT DAMAGE. THE PROCEDURE WAS NOT COMPLETED, SITE HAD TO BE RE-GRAFTED AND THE PATIENT WILL RETURN TO A FUTURE APPOINTMENT TO PLACE A NEW IMPLANT.

  Patient problems: Bone Fracture(s)

  MAUDE report 23451800 ↗
• InjuryOct 30, 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 #18 WAS REMOVED DUE TO NERVE INJURY. PATIENT NOTED PARESTHESIA AT IMPLANT SITE. IMPLANT MOBILITY WAS NOTED. THE IMPLANT WAS REMOVED USING TORQUE WRENCH AND BONE GRAFT WAS PLACED. AN ADDITIONAL APPOINTMENT WAS ANTICIPATED TO REPLACE THE IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA AND PARESTHESIA.

  Patient problems: Nerve Damage; Paresthesia; Swelling/ Edema

  MAUDE report 23429825 ↗
• InjuryOct 22, 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 #37 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 23360575 ↗
• InjuryOct 22, 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 #35 WAS REMOVED DUE TO BONE LOSS.

  Patient problems: Osteolysis

  MAUDE report 23360425 ↗
• InjuryOct 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 WAS REMOVED DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23344490 ↗
• InjuryJul 8, 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 #31 WAS REMOVED DUE TO BONE LOSS. DURING PRE-RESTORATIVE CHECK, RADIOGRAPHIC EVIDENCE OF SEVERE BONE LOSS PROGRESSION.

  Patient problems: Osteolysis

  MAUDE report 22440296 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Sinus Perforation

  MAUDE report 22328501 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS BEEN EXPERIENCING PAIN SINCE THE PLACEMENT OF THE IMPLANTS AT TOOTH SITES #26 AND #30. THE IMPLANTS WERE REMOVED DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 22158738 ↗
• InjuryMay 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 #30 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22005666 ↗
• InjuryMay 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 LOCATION #3 FAILED FOUR (4) MONTHS AFTER PLACEMENT AND WAS REMOVED DUE TO PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21961966 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21599872 ↗
• InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PAIN AFTER RESTORATION NOTED, DISTAL POCKET ON IMPLANT. TOOTH NUMBER 31. IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA AND INFLAMMATION.

  Patient problems: Inflammation; Pain; Swelling/ Edema

  MAUDE report 21178181 ↗
• InjuryDec 11, 2024Adverse 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. TOOTH 3.

  Patient problems: Osteolysis

  MAUDE report 20906723 ↗
• InjuryDec 11, 2024Adverse 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 20906372 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #2 WAS REMOVED DUE TO BONE LOSS. THE IMPLANT WAS REMOVED & REPLACED THE SAME DAY.

  Patient problems: Osteolysis

  MAUDE report 20763460 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 26 WAS REMOVED DUE TO PERI-IMPLANTITIS. IT WAS NOTICED DURING A CHECK UP 2 MONTHS AFTER PLACING THE CROWN.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20722090 ↗
• InjuryOct 14, 2024Adverse 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. DURING FOLLOW UP PATIENT WAS COMPLAINING OF SEVERE PAIN AND GUMS WERE EXTREMELY IRRITATED. IMPLANT WAS REMOVED USING IMPLANT DRIVER, BONE GRAFT WITH PRP/PRF WAS PLACED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20438598 ↗
• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT FAILED TO INTEGRATE AND WAS REMOVED DUE TO PERI-IMPLANTITIS. TOOTH LOCATION IS UNKNOWN.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 20374956 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT FINAL CHECK, THE PATIENT WANTED TO WAIT TO SEE IF LONGER HEALING WOULD RESOLVE DISCOMFORT AROUND THE IMPLANT AT TOOTH LOCATION #14. HOWEVER DURING A TORQUE TEST, THE PA SHOWED BONE LOSS AND TENDERNESS WITH PALPATION. THE IMPLANT WAS THEN REMOVED.

  Patient problems: Discomfort; Osteolysis

  MAUDE report 20332991 ↗