MAUDE Adverse Event Report: BIOMET 3I T3 PRO NON-PLATFORM SWITCHED TAPERED IMPLANT 3.25MM (D) X 8.5MM (L); DENTAL IMPLANT

Catalog Number	T3ST3285
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor reported pain during implant placement at tooth site 34 and unk.Patient had great pain during placement although the nerve was far from the area.Procedure was completed with a new implant.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).D10.Concomitant medical products t3st3210, t3 pro non-platform switched tapered.Implant 3.25mm (d) x 10mm (l) lot 2023040401.H4: device manufacturer date unknown / not provided.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Zimvie received one (1) t3st3285, (t3® pro non-platform switched tapered implant 3.25mm (d) x 8.5mm (l)) for evaluation.Visual evaluation of the as returned device identified the implant with signs of use, apparent dried blood attached to external threads.No malfunction identified.- product within specs.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.Dhr review was completed for the subject lot number 2023041051.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 2023041051 for similar events and no other complaint was identified.Review completed utilizing keywords: pain.Based on the investigation and risk management file review, the most likely root causes determined from the investigation are customer error (improper techniques used) and patient factors.Therefore, based on the available information, a device malfunction did not occur.The reported event was non-verifiable with all the available information.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.

• Brand Name: T3 PRO NON-PLATFORM SWITCHED TAPERED IMPLANT 3.25MM (D) X 8.5MM (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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 17893487
• Report Number: 0001038806-2023-01928
• Device Sequence Number: 3470764
• Product Code: DZE
• UDI-Device Identifier: 00844868046905
• UDI-Public: (01)00844868046905(17)280512(10)2023041051
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 03/20/2024

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: T3ST3285
• Device Lot Number: 2023041051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2023
• 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: 10/09/2023
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2023
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT SEE H10 NARRATIVE.; DENTAL IMPLANT SEE H10 NARRATIVE.
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic