Trabecular Metal™ TMT4B10Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
All models of Trabecular Metal (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie Trabecular Metal dental implant is a small screw-shaped implant used as a root replacement for a missing tooth. The 29 reports mostly describe implants that broke or loosened, along with infection and bone loss around the implant site that led to removal;27 reports involved injuries and no deaths were reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00889024018938), received between Mar 19, 2020 and Sep 29, 2026 — classified as 27 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (8 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem19
- Fracture8
- Patient-Device Incompatibility2
- Detachment of Device or Device Component1
- Mechanical Problem1
Patient problems
- Unspecified Infection14
- Osteolysis13
- No Clinical Signs, Symptoms or Conditions10
- Inflammation5
- Pain4
- Hypersensitivity/Allergic reaction3
- Fistula2
- Discomfort1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Fracture
It was reported implant fracture. Procedure completed with another device. Tooth site 24.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929823 ↗MalfunctionJan 27, 2026Mechanical Problem
IT WAS REPORTED THE IMPLANT FOR SITE 7, THE MOUNT WILL NOT DISENGAGE FROM IMPLANT. PLACED A NEW IMPLANT IN SAME PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24193623 ↗MalfunctionJan 5, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE FIXTURE MOUNT WAS NOT ATTACHED TO THE IMPLANT. THE PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23967959 ↗InjuryOct 31, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23440370 ↗InjuryJul 18, 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 BONE LOSS. PATIENT CAME IN AFTER #27 IMPLANT FELL OUT AND NOTICED #22 IMPLANT WAS FAILING TOO. IMPLANT WAS REMOVED, TOOTH 22.
Patient problems: Osteolysis
MAUDE report 22541218 ↗InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT ATTENDED FOR THE IMPRESSIONS, AND INFECTION WAS SEATED ON THE BUCCAL SIDE OF THE PLACEMENT AREA (#UR6). DIAGNOSED WITH FISTULA AND ABSCESS SO IMPLANT WAS REMOVED DUE TO INFECTION. PATIENT WILL RETURN TO COMPLETE THE PROCEDURE.
Patient problems: Fistula; Unspecified Infection
MAUDE report 20707479 ↗InjuryOct 1, 2024Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20344480 ↗InjuryJun 4, 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 AND 21 WERE REMOVED DUE TO PERI-IMPLANTITIS. PAIN AND DISCOMFORT WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 19456727 ↗InjuryJun 4, 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 AND 21 WERE REMOVED DUE TO PERI-IMPLANTITIS. PAIN AND DISCOMFORT WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 19456724 ↗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 19446099 ↗InjuryMay 7, 2024Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT BROKE THE IMPLANT AT TOOTH LOCATION #18 IN HALF. THE DOCTOR USED A TREPHINE TO REMOVE THE REST OF THE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19260635 ↗InjuryMar 11, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED ALLERGIC REACTION. TOOTH SITE # 45.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 18873514 ↗InjuryMar 5, 2024Adverse 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: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 18840605 ↗InjuryOct 5, 2023Adverse 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. TOOTH LOCATION 45.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 17875008 ↗InjuryOct 3, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT ALSO FRACTURED AT THE BODY OF THE IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 17859364 ↗InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT THE PATIENT HAD AN ABSCESS AND SHOWED BONE LOSS AROUND THE IMPLANT AT TOOTH LOCATION #12. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 17842538 ↗InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 13, 2023Fracture; Fracture
IT WAS REPORTED THAT TWO IMPLANTS FRACTURED AFTER FIVE (5) YEARS OF USE. THE IMPLANTS WERE REMOVED THE IMPLANTS USING TREPHINE. THE DOCTOR REPORTED THAT THE PROCEDURE WAS NOT COMPATIBLE WITH THE PLACEMENT OF OTHER IMPLANTS. OSTEOLYSIS REPORTED AS A CONSEQUENCE OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; Osteolysis
MAUDE report 16156111 ↗InjuryJan 13, 2023Fracture; Fracture
IT WAS REPORTED THAT TWO IMPLANTS FRACTURED AFTER FIVE (5) YEARS OF USE. THE IMPLANTS WERE REMOVED THE IMPLANTS USING TREPHINE. THE DOCTOR REPORTED THAT THE PROCEDURE WAS NOT COMPATIBLE WITH THE PLACEMENT OF OTHER IMPLANTS. OSTEOLYSIS REPORTED AS A CONSEQUENCE OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16156081 ↗InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #10 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 16050374 ↗InjuryMar 2, 2022Adverse 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 AND BONE LOSS. PATIENT WILL RETURN FOR ADDITIONAL APPOINTMENTS. TOOTH # 21.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 13652322 ↗InjuryFeb 16, 2022Adverse 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 PERI-IMPLANTITIS WITH BONE LOSS. PATIENT WILL NOT RETURN FOR ADDITIONAL APPOINTMENTS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 13543682 ↗InjuryFeb 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ALLERGIC REACTION WITH THE IMPLANT AT TOOTH SITE #20 AND IT WAS REMOVED. PATIENT PRESENTED STATING SHE IS SWOLLEN AND IN PAIN. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA, INFLAMMATION, PAIN.
Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Pain; Swelling/ Edema
MAUDE report 13519145 ↗InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DR. INDICATED BONE LOSS. THE IMPLANT WAS REMOVED. TOOTH SITE # 14 (FDI).
Patient problems: Osteolysis
MAUDE report 13507926 ↗InjuryNov 11, 2021Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT THE PATIENT HAD CONTINUOUS PAIN AFTER PLACEMENT. AN ALLERGIC REACTION WAS SUSPECTED. BY THE TIME OF IMPLANT REMOVAL AN INFECTION WAS PRESENT. NON INTEGRATION AND INFLAMMATION WERE ALSO REPORTED.
Patient problems: Hypersensitivity/Allergic reaction; Inadequate Osseointegration; Inflammation; Pain; Unspecified Infection
MAUDE report 12797461 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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