MAUDE Adverse Event Report: ZIMVIE US CORP LLC T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 4 X 11.5MM; DENTAL IMPLANT

Catalog Number	BOST411
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant at tooth location 36 fractured after 7 years in patient mouth.Implant was loaded.Implant was removed, bone regeneration was performed.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4) a1: patient identifier unknown / not provided.A4: patient weight unknown / not provided.E1: reporter phone number unknown / not provided.

• Brand Name: T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 4 X 11.5MM
• 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: 25389285
• Report Number: 0001038806-2026-03024
• Device Sequence Number: 10719027
• Product Code: DZE
• UDI-Device Identifier: 00844868028932
• UDI-Public: (01)00844868028932(17)211004(10)2016091562
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K122300
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2026
• 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): 06/04/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/04/2021
• Device Catalogue Number: BOST411
• Device Lot Number: 2016091562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2026
• 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: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2016
• 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: 50 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic