MAUDE Adverse Event Report: ZIMVIE US CORP LLC T3® PRO TAPERED IMPLANT 6/5MM (D) X 10MM (L); Dental Implant

Catalog Number	T3PT6510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	04/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
It was reported that the implant at tooth site #14 was removed due to bone loss.There is bone loss to the second thread and the sixth thread on the distal of #14.(b)(6)2026-#14- the healing abutment was removed.The implant was removed using reverse torque.A full thickness flap was reflected.The osteotomy was debrided of all soft tissue down to healthy bone.All bony wall and the sinus floor were noted to be intact.Decorticated.The osteotomy was refined using osteotomes.No scout film was obtained.No surgical guide was used.A zb t3 pro tapered immediate molar 8 x 10 mm implant was placed.Torque >90 ncm.Co/ca/xe regeneross bone was used to graft the peri-implant defect.A cover screw was placed.Collatape was placed over the site and secured with 3-0 gut suture.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H6: event problem codes/evaluation codes.H10: additional narrative.Zimvie did not received one (1) unknown fractured zimmer screw for evaluation.Visual inspection could not be performed.Dhr, sterilization, and complaint history review could not be performed, as the subject lot number associated with the unknown zimmer screw is not available.Zimvie quality management system (qms) has controls in place to prevent the distribution of non-conforming product and ensure the product is within specifications.The investigation has been performed based on the available information using risk management file (rmf).The customer did not submit images for the reported event.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was torque applied during placement/ seating exceeds recommended value.The reported event was non-verifiable with all the available information.The product conformance was not verifiable as the product was not returned.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.A summary investigation has been completed for bone loss events recognizing that a definitive root cause cannot be identified due to a wide range of external factors (non-design or manufacturing related), including medical conditions (e.G., diabetes, poor bone quality, etc.) / patient habits (e.G., smoking) and surgical technique.Previously completed investigations for bone loss have not identified any signals indicating potential non-conformances affecting the manufacturing and sterilization processes.Furthermore, the probability of manufacturing or design defects that might lead to bone loss and escaping the available detections has been assessed and found remote and almost nonexistent.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.

• Brand Name: T3® PRO TAPERED IMPLANT 6/5MM (D) X 10MM (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: 25209900
• Report Number: 0001038806-2026-02753
• Device Sequence Number: 13362831
• Product Code: DZE
• UDI-Device Identifier: 00844868046813
• UDI-Public: (01)00844868046813(17)300130(10)2120026114
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K213672
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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,Followup
• Report Date (Section B): 09/29/2026

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: Other
• Device Catalogue Number: T3PT6510
• Device Lot Number: 2120026114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2025
• 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: 59 YR
• Patient Sex: Female