MAUDE Adverse Event Report: BIOMET 3I TSX IMPLANT, 3.7MMD, 16MML; DENTAL IMPLANT

Catalog Number	TSX37B16
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported big infection in dental implant at tooth site # 43.Implant was removed.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).D9: device availability unknown / not provided.A summary investigation has been completed for infection events identifying that a definitive root cause cannot be identified due to the wide range of external (non-design/ non-manufacturing related) factors potentially impacting the sterility of the implant and its environment.Should additional information be received which indicates that the device may have caused or contributed to the infection event, an additional report will be submitted.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.D9: device availability.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.Dhr review was completed for the subject lot number 1271927.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Sterilization record was reviewed and verified to have passed all sterilization activities with no issues or nonconformities identified.Complaint history review was performed for the reported lot number 1271927 for similar events and no other complaint was identified.Review completed utilizing keywords: infection.

• Brand Name: TSX IMPLANT, 3.7MMD, 16MML
• 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: 22880286
• Report Number: 0001038806-2025-01994
• Device Sequence Number: 18465032
• Product Code: DZE
• UDI-Device Identifier: 00844868045076
• UDI-Public: (01)00844868045076(17)250827(10)1271927
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K220978
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2025

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: 08/27/2025
• Device Catalogue Number: TSX37B16
• Device Lot Number: 1271927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/23/2025
• Supplement Report FDA Received Date: 09/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2023
• 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: 54 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic