MAUDE Adverse Event Report: BIOMET 3I TSX¿ IMPLANT, 3.1MMD, 13MML; DENTAL IMPLANT

Catalog Number	TSX31B13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sinus Perforation (2277)
Type of Reportable Event	Serious Injury
Event or Problem Description
Sinus perforation reported.Therefore, the implant was removed.Tooth number 6.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: weight unknown / not provided.B3: date of event unknown / not provided.Product has been received by zimvie and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This report is being submitted to relay corrected data and additional information.Correction: the device available for evaluation was updated to no.Section b1 - product problem was checked in error.The following sections are being reported: d4: udi number was removed.H6: component code was added: 4115.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
Upon follow-up the product returned information was updated.
Event or Problem Description
No additional event information received at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.D9: device availability and return date were updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation code were added: 3331 and 4110.H10: narrative/data was updated.Zimvie received the reported implant for evaluation.Visual evaluation was performed.However, no apparent damage / malfunction that would cause or contribute to the reported events was identified.Dhr review was completed for the subject lot number.No deviations or non-conformances, which could have caused or contributed to the reported events, were noted as part of the dhr.Based on the available information, a device malfunction did not occur.The reported events are 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 products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.

• Brand Name: TSX¿ IMPLANT, 3.1MMD, 13MML
• 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: 21337176
• Report Number: 0001038806-2025-00292
• Device Sequence Number: 12917576
• Product Code: DZE
• UDI-Device Identifier: 00844868045014
• UDI-Public: (01)00844868045014(17)250927(10)1272339
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K220978
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/26/2025
• Device Catalogue Number: TSX31B13
• Device Lot Number: 1272339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2025
• 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; Not provided
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 02/10/2025; 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic