MAUDE Adverse Event Report: BIOMET 3I 3I T3 TAPERED IMPLANT 4/3 X 8.5MM; DENTAL IMPLANT

Catalog Number	BOPT4385
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	02/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.E1: last name unknown / not provided.
Event or Problem Description
It was reported that patient had titanium allergy, failed 3 mon after placement.Tooth 4.Implant was removed.Additional appointment required for ridge augmentation.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Zimvie received one (1) (b)(6) (3i t3 tapered implant 4/3 x 8.5mm) for evaluation.Visual evaluation was performed.The returned implant has signs of use, apparent bone / tissue attached to external threads.The implant was identified as reported however, no apparent malfunction was identified with the implant that would contribute to the reported event.Implant matched prints where measured.Dhr review was completed for the subject lot number 2019012019.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 2019012019 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿dental : medical : allergic reaction¿ the customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-00053-haz rev 12, the most likely root cause determined from the investigation was patient factors.Therefore, based on the available information, a device malfunction did not occur.The implant was returned with no damage that would cause or contribute to the event.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.The following sections have been updated: b4: date of this report.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H3: changed "no" to "yes".H6: entered evaluation codes.H10: added manufacturer narrative.

• Brand Name: 3I T3 TAPERED IMPLANT 4/3 X 8.5MM
• 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: 21805957
• Report Number: 0001038806-2025-00781
• Device Sequence Number: 17994363
• Product Code: DZE
• UDI-Device Identifier: 00844868028499
• UDI-Public: (01)00844868028499(17)240215(10)2019012019
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K122300
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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: Lay User/Patient
• Device Expiration Date: 02/15/2024
• Device Catalogue Number: BOPT4385
• Device Lot Number: 2019012019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2025
• 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: 04/09/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2019
• 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: 47 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic