Trabecular Metal™ TMM4B10Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00889024018808), received between Mar 18, 2020 and Aug 25, 2025 — classified as 14 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (10 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 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2025Fracture; Fracture

  THE DOCTOR REPORTS THAT THE DENTAL IMPLANT IN POSITION 25 FAILED DUE TO A FRACTURE AT THE APICAL THIRD DURING THE SURGICAL PROCEDURE. THE DOCTOR REPORTS THAT THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER IMPLANT. THE REST OF THE IMPLANT WAS REMOVED FROM PATIENT'S MOUTH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881911 ↗
• InjuryApr 22, 2025Fracture; Fracture

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

  Patient problems: Pain

  MAUDE report 21879963 ↗
• MalfunctionApr 22, 2025Fracture; Fracture

  DOCTOR REPORTED THAT IN THE SAME SESSION, A PATIENT WAS SCHEDULED WITH 2 TABECULAR METAL IMPLANTS. THE IMPLANTS WERE POST EXTRACTIONAL IN QUADRANT 3. THE DOCTOR PLACED THE FIRST TRABECULAR METAL ON TOOTH 36 WITH NO PROBLEMS. AFTER THAT, HE WANTED TO PLACE THE SECOND TRABECULAR IMPLANT ON TOOTH 35. HE TOOK IT FROM THE PACKAGE, HE PLACED THE IMPLANT IN THE SOCKET , BUT THE IMPLANT WASN'T GOING FORWARD. HE REMOVED THE IMPLANT FROM THE SOCKET TO SEE WHAT IS HAPPENING AND SAW THAT THE APICAL PART WAS FRACTURED AND BLOCKED IN THE ALVEOLUS. HE STRUGGLED HARD TO REMOVE THE APICAL PART REMAINED IN THE ALVEOLUS. THE PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT: TSV6B10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21879842 ↗
• InjuryNov 8, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20638935 ↗
• InjuryJun 3, 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 36 WAS REMOVED DUE TO PERI-IMPLANTITIS. PROCEDURE WAS NOT COMPLETED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19446380 ↗
• InjuryJun 3, 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 15 WAS REMOVED DUE TO PERI-IMPLANTITIS. DISCOMFORT WAS REPORTED AS A RESULT OF THE EVENT. PROCEDURE WAS NOT COMPLETED.

  Patient problems: Discomfort; Osteolysis; Unspecified Infection

  MAUDE report 19446319 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES 11, 21 WERE REMOVED DUE TO PERI-IMPLANTITIS.. DISCOMFORT WAS REPORTED AS A RESULT OF THE EVENT. PROCEDURE WAS NOT COMPLETED.

  Patient problems: Discomfort; Osteolysis; Unspecified Infection

  MAUDE report 19445790 ↗
• InjuryMar 11, 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 36 WAS REMOVED DUE TO BONE LOSS AND INFECTION. DURING REMOVAL THE IMPLANT FRACTURED AT THE BODY OF THE IMPLANT. ABSCESS, EDEMA AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT. PATIENT HAD TO RETURN TO PLACE A NEW IMPLANT.

  Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection

  MAUDE report 18874082 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED PERI-IMPLANTITIS WITH ABSCESS, EDEMA, INFLAMMATION AND PAIN AT TOOTH SITE 29. THERE WAS PUS AND SWELLING AROUND IMPLANT HEAD. PATIENT HAS BEEN RESCHEDULED FOR NEW IMPLANT PLACEMENT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17666844 ↗
• InjuryAug 2, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 46 FRACTURED AT THE SUPERIOR CRESTAL JUNCTION OF TANTALUM WITH TITANIUM. THE IMPLANT WITH CROWN ATTACHED WAS REMOVED DUE TO THE FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17442851 ↗
• InjuryJun 27, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH #4 FRACTURED IN THE PATIENT'S MOUTH AND WAS REMOVED. THE SITE WAS GRAFTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14831674 ↗
• InjuryJun 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT AT SITE 3 (UNIVERSAL) FRACTURED AND WAS REMOVED AND THE SITE WAS GRAFTED WITH ALLOGRAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14678945 ↗
• InjuryJun 10, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO A FRACTURE ON THE IMPLANT.

  Patient problems: Pain

  MAUDE report 14652736 ↗
• MalfunctionJan 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT FRACTURED IN THE PATIENT'S MOUTH. THE IMPLANT WAS PLACED CLOSED TO THE SINUS AND AT THIS POINT IN ORDER TO AVOID PERFORATION, THE IMPLANT WILL STAY IN THE PATIENTS MOUTH. THEY WILL CALL AT A LATER DAT IF THEY DECIDE TO REMOVE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13385899 ↗
• InjurySep 10, 2021Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT HAS BEEN FRACTURED "IN HALF" AND ALSO REPORTS PERI-IMPLANTITIS. THE DOCTOR ALSO CONFIRMS THAT THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT ON THE SAME DAY AND THAT THE PATIENT WILL HAVE TO RETURN IN THE FUTURE TO REMOVE THE BROKEN IMPLANT. THE DOCTOR CONFIRMS THAT THE PATIENT DID NOT SUFFER ANY NEGATIVE IMPACT ON HIS HEALTH.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 12452026 ↗
• InjuryJan 11, 2021Adverse 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, SITE WAS INFLAMMATED.

  Patient problems: Unspecified Infection

  MAUDE report 11145609 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT COULD NOT BE PLACED DUE TO LACK OF PRIMARY STABILITY AT TOOTH LOCATION 13. PATIENT TO RETURN FOR IMPLANT PLACEMENT.

  Patient problems: No Information

  MAUDE report 9850005 ↗