MAUDE Adverse Event Report: BIOMET 3I T3 PRO NON-PLATFORM SWITCHED TAPERED IMPLANT 3.25MM (D) X 10MM (L); DENTAL IMPLANT

Catalog Number	T3ST3210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Zonular Dehiscence (2698)
Date of Event	10/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint (b)(4).A4: patient weight is not provided / unknown.
Event or Problem Description
It was reported that the implant at tooth site #22 was placed and immediately removed due to facial bone dehiscence.
Additional Manufacturer Narrative
Zimvie complaint (b)(4).Zimvie received one (1) t3st3210, (t3 pro non-platform switched tapered implant 3.25mm (d) x 10mm (l) for evaluation.Visual evaluation was performed, the implant had bone debris on its internal and external threads.No damage or signs of malfunction that would have contributed to the event.Measurements match drawing.Dhr review was completed for the subject lot number 2120005282.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 2120005282 for similar events and no other complaint was identified.Review completed utilizing keywords: dental: medical: other and dental: functional: lack of primary stability.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 inadequate treatment planning.Therefore, based on the available information, a device malfunction did not occur.No damage to the implant was identified.The reported event was non-verifiable.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.Similar complaints for the inability to achieve primary stability (unable to place implant into osteotomy) have been previously investigated.Refer to attached summary investigation.Visual and dimensional evaluations of the previously returned product have not identified or suggested manufacturing non-conformances.While non-conformances were identified for some lots during manufacturing records reviews, the documented disposition actions for each have not suggested the likely release of non-conforming product.To date, all complaint data was found to be conforming and did not meet capa/hhe/d/ or any further escalations.Therefore, there were no complaints which confirmed a manufacturing or design related issue caused or contributed to the reported event.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 PRO NON-PLATFORM SWITCHED TAPERED IMPLANT 3.25MM (D) X 10MM (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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 20817505
• Report Number: 0001038806-2024-02764
• Device Sequence Number: 7850602
• Product Code: DZE
• UDI-Device Identifier: 00844868046868
• UDI-Public: (01)00844868046868(17)281025(10)2120005282
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K213672
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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: Health Professional
• Device Catalogue Number: T3ST3210
• Device Lot Number: 2120005282
• 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: 12/02/2024
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic