MAUDE Adverse Event Report: BIOMET 3I T3¿ PRO NON-PLATFORM SWITCHED TAPERED IMPLANT 4MM (D) X 11.5MM (L); DENTAL IMPLANT

Catalog Number	T3ST411
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
The doctor reports that the cover screw became stuck inside the implant at tooth site 15 and could not be removed, so the implant also had to be taken out.The procedure was completed by placing a new implant.
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, d3: email address, g1: contact office - first/given name, last name and email address, g1: contact office - manufacturer site - email address, g3: date received by manufacturer , g6: type of report, h1: type of reportable event, h2: follow up type, h3: device evaluated by manufacturer, h6: adverse event problem, h10: additional narrative.Zimvie received one (1) t3st411, (t3 pro non-platform switched tapered implant 4mm (d) x 11.5mm (l)) for evaluation.Visual evaluation and a functional test were performed, the implant had signs of use with bone debris on its external threads.A cover screw was attached to the implant and couldn¿t be disengaged.There was damage to the covers screw drive feature.Additional information was obtained on 03-sep-2025 regarding the inspection findings, the covers screws drive feature damage occurred during the removal process.Dhr review was completed for the subject lot number 2120013411.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 2120013411 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental: functional: does not disengage/release¿ based on the investigation and risk management file review, the most likely root cause determined from the investigation was customer error ¿ excessive torque used to place implant cover screw.Therefore, based on the available information, a device malfunction did occur.The cover screw was attached to the implant and couldn¿t be disengaged.The reported event was confirmed.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.

• Brand Name: T3¿ PRO NON-PLATFORM SWITCHED TAPERED IMPLANT 4MM (D) X 11.5MM (L)
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: mark mashburn ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 22910642
• Report Number: 0001038806-2025-02039
• Device Sequence Number: 21137580
• Product Code: DZE
• UDI-Device Identifier: 00844868046929
• UDI-Public: (01)00844868046929(17)290505(10)2120013411
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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: T3ST411
• Device Lot Number: 2120013411
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/05/2025
• 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: 08/28/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2024
• 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
• Patient Age: 81 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic