MAUDE Adverse Event Report: ZIMVIE US CORP LLC T3® TAPERED IMPLANT 5/4 X 10MM; DENTAL IMPLANT

Catalog Number	BOPT5410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Pain (1994)
Date of Event	01/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.D6: d6a.If implanted, unknown.D9: device availability: remains implanted.D10.Concomitant medical products.Iunihg, certain gold-tite hexed screw lot unknown x 2.Bopt6585, t3® tapered implant 6/5 x 8.5mm lot 2021110551.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
Doctor reported loosening of both gold screws at tooth sites 46 and 47 at the screwed implants.They seemed to have failed or to have been loose.Doctor also indicated infection and inflammation, it was treated and implants remain implanted.Patient referred pain.Patient has been rescheduled for new prosthesis and screws.This complaint refers to the infection in the site.

• Brand Name: T3® TAPERED IMPLANT 5/4 X 10MM
• 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: 24660437
• Report Number: 0001038806-2026-01517
• Device Sequence Number: 9243323
• Product Code: DZE
• UDI-Device Identifier: 00844868028505
• UDI-Public: (01)00844868028505(17)271222(10)2022120054
• 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
• 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): 03/23/2026

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: BOPT5410
• Device Lot Number: 2022120054
• Was Device Available for Evaluation?: No
• 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: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/22/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL PRODUCTS SEE H10 NARRATIVE
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic