MAUDE Adverse Event Report: ZIMVIE US CORP LLC T3 PRO TAPERED IMPLANT 5/4MM (D) X 11.5MM (L); DENTAL IMPLANT

Catalog Number	T3PT5411
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)
Date of Event	10/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: weight unknown / not provided a summary investigation has been completed for infection events identifying that a definitive root cause cannot be identified due to the wide range of external (non-design/ non-manufacturing related) factors potentially impacting the sterility of the implant and its environment.Should additional information be received which indicates that the device may have caused or contributed to the infection event, an additional report will be submitted.
Event or Problem Description
It was reported that the implant at tooth site #13 was removed due to infection.On (b)(6) 2025, a subperiosteal infection was noted at site #13.A vestibular incision was made and approximately 2cc of purulence was evacuated from the space.The area was explored and debrided using hemostats and scissors.The site was thoroughly irrigated.The incision was left to heal by secondary intention.Patient tolerated the procedure well.On (b)(6) 2025, the screw access hole was uncovered and the temporary restoration was removed.The implant was removed using reverse torque.A full thickness flap was reflected.A small amount of purulence was evacuated from the site.The buccal space was explored using scissors.No significant purulence was encountered.A prf membrane was placed at the site.Soft tissues were reapproximated with 3-0 chromic suture.Site grafting and a replacement implant were anticipated in the future once the infection has resided.Symptoms as a result of the event: inflammation, pain and swelling.

• Brand Name: T3 PRO TAPERED IMPLANT 5/4MM (D) X 11.5MM (L)
• 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: 23503838
• Report Number: 0001038806-2025-03017
• Device Sequence Number: 9106358
• Product Code: DZE
• UDI-Device Identifier: 00844868046776
• UDI-Public: (01)00844868046776(17)271116(10)2022110115
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K130949
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2025

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: T3PT5411
• Device Lot Number: 2022110115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic