MAUDE Adverse Event Report: ZIMVIE US CORP LLC T3® TAPERED IMPLANT 5/4 X 8.5MM; DENTAL IMPLANT

Catalog Number	BOPT5485
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.
Event or Problem Description
It was reported that an implant at tooth site # 16 came out of its pouch.After following up with the doctor, it was confirmed that the implant came out of its pouch and fell from the driver onto the floor right before placing it in the patient¿s mouth.It was confirmed that the procedure was completed.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) bopt5485, (t3® tapered implant 5/4 x 8.5mm) for evaluation.Visual evaluation and a functional test were performed, the returned implants outer box and inner tray packaging were not returned.Only the implant was returned.The implant engaged and disengaged with an in-house driver as intended.Measurements match drawing.Dhr review was completed for the subject lot number 2120038521.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 2120038521 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental : functional : disengaged¿ based on the investigation and risk management file review, the most likely root cause determined from the investigation was customer error ¿ device was not transferred from sterile environment to patient in accordance with ifu.Therefore, based on the available information, a device malfunction did not occur.No damage to the implant was identified.The reported event was unconfirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were 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 is available at the time of this report.

• Brand Name: T3® TAPERED IMPLANT 5/4 X 8.5MM
• 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: 24474640
• Report Number: 0001038806-2026-01071
• Device Sequence Number: 21402147
• Product Code: DZE
• UDI-Device Identifier: 00844868028529
• UDI-Public: (01)00844868028529(17)301027(10)2120038521
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K122300
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

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: BOPT5485
• Device Lot Number: 2120038521
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/02/2026
• 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: 02/27/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2025
• 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: 57 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic