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	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported implant #31 placed guided using tapered navigator certain kit.Implant was ref: t3pt5410 lot: 2120028990, torqued in at 30 ncm.Bone profiler used.Encodes that were tried in: ref: ieeha477 lot: 1266047 x2 and ref: ieeha467 lot: 1260022.The encodes did not seat.Dr.Then reengaged the implant mount and also engaged the internal connection universal placement driver tip.He decided to remove the implant and place another one.Implant placed: ref: t3pt5410 lot: 2120026483.After dr.Opened the implant he tried in one of the encodes listed above to see if it would seat, it did.He placed the new implant and put encode ref: ieeha477 lot: 1266047.Possible internal threads damaged.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Additional Manufacturer Narrative
Zimvie received one (1) t3pt5410 (t3® pro tapered implant 5/4mm (d) x 10mm (l)) for evaluation.Visual evaluation was performed.The reported implant was returned used.Bone and blood residue was observed on its external and internal threads.No packaging was returned.Both returned encode abutments were functionally tested with an in-house biomet implant and both engage, disengage and seat as intended.Returned implant inner threads show signs of damage.The coob is non-verifiable as the condition of the product when received by the customer is unknown / non-verifiable.Dhr review was completed for the subject lot number 2120028990.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 2120028990 for similar events, and no other complaint was identified.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 or speed applied during placement/seating exceeds recommended value.Therefore, based on the available information, a device malfunction did occur.Implant drive feature was observed to be damaged.The reported event was confirmed.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.
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: 24072976
• Report Number: 0001038806-2026-00266
• Device Sequence Number: 15731663
• Product Code: DZE
• UDI-Device Identifier: 00844868046769
• UDI-Public: (01)00844868046769(17)300319(10)2120028990
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: T3PT5410
• Device Lot Number: 2120028990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2025
• 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: 75 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic