Trabecular Metal™ TMT6B11Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024018976), received between Jan 10, 2020 and May 20, 2025 — classified as 8 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 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 FAILED THE TORQUE TEST AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS; INFLAMMATION; PAIN & SWELLING.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 22052965 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. DISCOVERED DURING CLINICAL PROCEDURE. IMPLANT REMOVED WITH BONE GRAFTING, IMPLANT PLACEMENT IN 3 MONTHS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 22038602 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PERI-IMPLANTITIS AND BONE LOSS, TOOTH 12. LOSS OF BONE SURROUNDING IMPLANT PARTICULARLY TO THE BUCCAL. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, BONE LOSS, DEHISCENCE, INFLAMMATION, PAIN. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. WAS THERE A DELAY DURING THE PROCEDURE: NO. ADDITIONAL APPOINTMENT REQUIRED: YES. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE: NO.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 18508287 ↗
• InjuryOct 25, 2023Adverse 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 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AT THE IMPLANT SITE AND WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, EDEMA, INFLAMMATION AND PAIN.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 18004830 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR DID A CRESTAL SINUS LIFT AND PLACED AN IMPLANT AT TOOTH LOCATION #3. THE IMPLANT WENT INTO THE SINUS AND THE DOCTOR HAD TO GO IN LATERALLY TO REMOVE THE IMPLANT.

  Patient problems: Sinus Perforation

  MAUDE report 17258993 ↗
• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

  Patient problems: Osteolysis

  MAUDE report 16529060 ↗
• InjuryAug 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR INDICATED LACK OF PRIMARY STABILITY AT TOOTH SITE #26. PATIENT TO RESCHEDULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12276076 ↗
• InjuryJan 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR WAS UNABLE TO PLACE THE IMPLANT INTO THE PATIENT'S OSTEOTOMY DUE TO A LACK OF PRIMARY STABILITY. PATIENT WILL RETURN FOR REPLACEMENT OF IMPLANT IN 6 MONTHS.

  Patient problems: No Information

  MAUDE report 9577451 ↗