MAUDE Adverse Event Report: ZIMVIE US CORP LLC T3® WITH DCD® EX HEX PARALLEL WALLED IMPLANT 4 X 6.5MM; DENTAL IMPLANT

Catalog Number	BNES465
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
The doctor reports that the implant at tooth site 36 has a damaged hexagon and was removed.No negative impact on the patient¿s health was reported as a consequence of the event.The procedure was completed using another implant.

• Brand Name: T3® WITH DCD® EX HEX PARALLEL WALLED IMPLANT 4 X 6.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: mark mashburn ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 24829765
• Report Number: 0001038806-2026-01900
• Device Sequence Number: 10220248
• Product Code: DZE
• UDI-Device Identifier: 00844868032847
• UDI-Public: (01)00844868032847(17)280918(10)2120003137
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K133049
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: BNES465
• Device Lot Number: 2120003137
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic