MAUDE Adverse Event Report: BIOMET 3I 3I T3 WITH DCD TAPERED IMPLANT 4/3 X 11.5MM; DENTAL IMPLANT

Catalog Number	BNPT4311
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that implant caused ulcerations of the tissue in the vestibule and her denture could be worn over top.The implant was removed due to ulceration.There is an ulceration of the lower left lip.The ulceration approximates to the cover screw at site #22.There is a large ulceration that is tender to palpation.The ulceration approximates to the locator attachment at site #27.A full thickness flap from implant was reflected.A trephine bur was used to remove bone.Implant was then removed using forceps.Soft tissues were reapproximated using 4-0 chromic suture.Symptoms as a result of the event: pain.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.
Additional Manufacturer Narrative
Zimvie received one (1) bnpt4311, (3i t3® with dcd® tapered implant 4/3 x 11.5mm) for evaluation.Visual evaluation of the as returned device identified the implant with signs of use, apparent bone / tissue attached to external threads.However, no apparent malfunction was identified with the implant that would contribute to the reported event.Implant matched prints where measured.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 2020011270.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 2020011270 for similar events and one (1) other complaint was identified (b)(4).Review completed utilizing keywords: ¿medical other¿.The customer did not submit images for the reported event.Based on the investigation and risk management file review as per rmf rm-00053-haz rev.12, the most likely root cause determined from the investigation is inadequate treatment planning.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.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: 3I T3 WITH DCD TAPERED IMPLANT 4/3 X 11.5MM
• 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: 22198151
• Report Number: 0001038806-2025-01332
• Device Sequence Number: 15601828
• Product Code: DZE
• UDI-Device Identifier: 00844868028338
• UDI-Public: (01)00844868028338(17)250211(10)2020011270
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: 2021
• 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): 08/06/2025

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: Other
• Device Expiration Date: 02/11/2025
• Device Catalogue Number: BNPT4311
• Device Lot Number: 2020011270
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/29/2025
• 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: 06/12/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic