MAUDE Adverse Event Report: ZimVie US Corp LLC T3® PARALLEL WALLED IMPLANT 5/4 X 8.5MM; Dental Implant

Catalog Number	BOPS5485
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor reported severe pain following implant placement at tooth site 26; no improvement in the pain despite antibiotic treatment and the implant was removed.Symptom-free 10 days after implant removal.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight: unknown / not provided.

• Brand Name: T3® PARALLEL WALLED IMPLANT 5/4 X 8.5MM
• 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 ; +1(561)971-3230
• MDR Report Key: 50080383
• Report Number: 0001038806-2026-04017
• Device Sequence Number: 18727700
• Product Code: DZE
• UDI-Device Identifier: 00844868028451
• UDI-Public: (01)00844868028451(17)280202(10)2023011093
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K122300
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: BOPS5485
• Device Lot Number: 2023011093
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/13/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female