MAUDE Adverse Event Report: BIOMET 3I T3 PRO TAPERED IMPLANT 4/3MM (D) X 8.5MM (L); DENTAL IMPLANT

Catalog Number	T3PT4385
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994); Paresthesia (4421)
Date of Event	09/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided d10.Concomitant medical products t3pt5485, t3 pro tapered implant 5/4mm (d) x 8.5mm (l) lot 2120002456 and t3pt4311, t3 pro tapered implant 4/3mm (d) x 11.5mm (l) lot 2120004471.
Event or Problem Description
It was reported nerve damage at tooth site 46 observed during clinical procedure.A shorter implant was going to be placed due to nerve proximity, nevertheless, the patient reported high pain and an additional appointment was required.Symptoms suffered by the patient: paresthesia and pain.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.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) t3pt5485, (t3 pro tapered implant 5/4mm (d) x 8.5mm (l)) for evaluation.Visual evaluation was performed, the implants showed signs of wear/use, however, no damage that would cause or contribute to the event was identified.Measurements match drawing.Device history record (dhr) review was completed for the subject lot number 2120002484.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 2120002484 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : medical : other.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was customer error.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.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 TAPERED IMPLANT 4/3MM (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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 20704003
• Report Number: 0001038806-2024-02661
• Device Sequence Number: 9782870
• Product Code: DZE
• UDI-Device Identifier: 00844868046752
• UDI-Public: (01)00844868046752(17)280913(10)2120002484
• 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
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 01/12/2025

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: T3PT4385
• Device Lot Number: 2120002484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2024
• 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: 11/18/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2023
• 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
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic