3i T3® DCD® BNES565Recalls & reported problems
ZimVie US Corp LLC · 3I T3® WITH DCD® EX HEX PARALLEL WALLED IMPLANT 5 X 6.5MM · Class 2 · Implant
All models of 3i T3 DCD (73)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00844868032915), received between Sep 3, 2019 and Jan 8, 2025 — classified as 5 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem5
Patient problems
- Osteolysis3
- Unspecified Infection3
- Inflammation2
- Swelling/ Edema2
- Abscess1
- No Code Available1
- No Information1
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #26 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. EDEMA AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 21101015 ↗InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #16 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. THE DOCTOR REPORTED PAIN AND INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 19643036 ↗InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER #16 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER FORM THAT THE PROCEDURE WAS NOT CONCLUDED WITH ANOTHER IMPLANT. THE DOCTOR REPORTS: EDEMA, INFLAMMATION, PAIN AND ABSCESS.
Patient problems: Abscess; Inflammation; Osteolysis; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 16383532 ↗InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTS PRIMARY STABILITY WAS NOT ACHIEVED FOR BNES565 IMPLANT.
Patient problems: No Information
MAUDE report 9714580 ↗InjurySep 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED LACK OF PRIMARY STABILITY. ANOTHER IMPLANT WILL BE PLACED IN 6 MONTHS.
Patient problems: No Code Available
MAUDE report 8955313 ↗
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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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