MAUDE Adverse Event Report: BIOMET 3I T3 PRO NON-PLATFORM SWITCHED TAPERED IMPLANT 4MM (D) X 10MM (L); DENTAL IMPLANT

Catalog Number	T3ST410
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
Doctor reported that when opening the implant blister he noticed that the implant inside the blister was not 8.5 but 10.Patient has been sent home.No implant placed.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) t3st410, (t3 pro non-platform switched tapered implant 4mm (d) x 10mm (l)) for evaluation.A visual evaluation was performed, the returned implant has signs of use, and was identified as reported (t3st410) implant matched prints where measured.The implant's outer box was observed already opened, and the tamper seal was seen broken.Additionally, the inner tray was not returned for evaluation.The coob is non-verifiable since the condition of the product / packaging delivered to the customer is unknown / non-verifiable.Device history record (dhr) review was completed for the subject lot number 2120017536.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 2120017536 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : packaging : incorrect product the customer did submit images for the reported event.The images was of a an opened tsx6b8 implant package.Based on the investigation and risk management file review, the most likely root cause determined was improper handling of product outside of zimvie controls.Therefore, based on the available information, a packaging malfunction could not be verified.The implants packaging was opened, and the implants tamper seal was broken.The implant also appeared to have signs of use.The reported event/coob is non-verifiable since the condition of the product/packaging received by the customer was unknown.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 PRO NON-PLATFORM SWITCHED TAPERED IMPLANT 4MM (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: 20999300
• Report Number: 0001038806-2024-02987
• Device Sequence Number: 6781338
• Product Code: DZE
• UDI-Device Identifier: 00844868046912
• UDI-Public: (01)00844868046912(17)290730(10)2120017536
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K213672
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/16/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: T3ST410
• Device Lot Number: 2120017536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2024
• 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: 12/23/2024
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic