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

Catalog Number	T3PT5410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	12/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.
Event or Problem Description
It was reported that the cause for the failed implant was patient's medical condition of scleroderma.The clinician placed the implant on site #3 on (b)(6) 2025 with no issues.On (b)(6) 2025 patient returned to the office for post op appt.At first post operative appointment following dental implant procedure found dental implant 3 lost primary stability despite initial great stability at 50-55 ncm and pain to rotation with hand driver.In this appt doc saw the implant was not integrated so he tried screwing it deeper to see if it would integrate.Could not get dental implant to re-establish stability by seating more apical.Removed.Bone found attached to implant threads - complication due to severe case of scleroderma.After that doc saw the implant was still not integrated so he removed it.He came to the conclusion the implant failed due to her medical condition as that can cause bone loss.The procedure was not completed using another implant, removed failed implant, placed regeneross cone compressed into osteotomy, then minimized explant site and secured regeneross with 2, 4-0 cg sutures.
Additional Manufacturer Narrative
Zimvie received one (1) t3pt5410, (t3® pro tapered implant 5/4mm (d) x 10mm (l)) for evaluation.Visual evaluation of the as returned device identified the implant with signs of use, apparent bone / tissue attached to external threads and was observed attached to an encode abutment.No allegations were reported against the encode abutment and no apparent malfunction was identified.The implant was identified as reported however, no apparent malfunction was identified with the implant that would contribute to the reported event.Implant matched prints where measured.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 2120021311.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2120021311 for similar events and no other complaint was identified.The customer did submit ten (10) x-ray images for the reported event.Based on the investigation and risk management file review the most likely root causes determined from the investigation are inadequate treatment planning, and patient factors.Therefore, based on the available information, the implant malfunction did not occur.The reported event was confirmed with all the available information.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.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.The following sections have been updated: b4: date of this report.D9: device availability.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H3: changed "no" to "yes".H6: entered evaluation codes.H11: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: T3® PRO TAPERED IMPLANT 5/4MM (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: 24595224
• Report Number: 0001038806-2026-01373
• Device Sequence Number: 21079026
• Product Code: DZE
• UDI-Device Identifier: 00844868046769
• UDI-Public: (01)00844868046769(17)291017(10)2120021311
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: 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,Followup
• Report Date (Section B): 04/03/2026

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: T3PT5410
• Device Lot Number: 2120021311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2024
• 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: 64 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic