3i T3® SHORT DCD® BNES506Recalls & reported problems
ZimVie US Corp LLC · 3i T3® SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT WITH DCD®, 5MM(D) X 6MM(L) · Class 2 · Implant
All models of 3i T3 SHORT DCD (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00844868033608), received between Oct 1, 2019 and Jul 28, 2026 — classified as 7 injuries, 1 malfunction.
The most frequently reported specific device problem is “Separation Failure” (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. 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 Problem7
- Separation Failure1
Patient problems
- Unspecified Infection5
- Osteolysis4
- Inflammation2
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the dental implant at Tooth Site 16 failed due to peri-implantitis. Inflammation was also reported.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 50052227 ↗InjuryJan 9, 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 #36 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21110458 ↗MalfunctionJul 19, 2023Separation Failure; Separation Failure
THE DOCTOR REPORTS THAT THE MOUNT IS LOCKED INSIDE THE IMPLANT DESPITE COMPLETELY REMOVING THE SCREW. THE AFFECTED TOOTH POSITION IS #36. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17354873 ↗InjuryJan 20, 2023Adverse 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 AT THE IMPLANT SITE.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 16218750 ↗InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DENTAL IMPLANT FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR CONFIRMED THAT THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT AND THAT THE PATIENT DID NOT SUFFER ANY NEGATIVE IMPACT ON HIS HEALTH AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 15073544 ↗InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED LACK OF PRIMARY STABILITY AT TOOTH LOCATION #18.
Patient problems: No Code Available
MAUDE report 11165320 ↗InjuryDec 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IMPLANT REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 9471969 ↗InjuryOct 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTS THAT PRIMARY STABILITY WAS NOT ACHIEVED FOR IMPLANT (B)(4).
Patient problems: Inflammation
MAUDE report 9141887 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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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