MAUDE Adverse Event Report: ZIMVIE US CORP LLC TSX IMPLANT, 4.7MMD, 10MML; DENTAL IMPLANT

Catalog Number	TSX47B10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Osteolysis (2377)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).D4: lot number unknown / not provided.D4: expiration date unknown / not provided.D4: unique device identifier (udi) unknown / not provided.D6a: date of implant unknown / not provided.D6b: date of removal unknown / not provided.G4: pma/510(k) number unknown / not provided.H4: device manufacture date unknown / not provided.A summary investigation has been completed for peri-implantitis events recognizing that a definitive root cause cannot be identified due to a wide range of external factors (non-design or manufacturing related), including medical conditions (e.G., diabetes, poor bone quality, etc.) / patient habits (e.G., smoking) and surgical technique.Previously completed investigations for these events have not identified any signals indicating potential non-conformances affecting the manufacturing and sterilization processes.Furthermore, the probability of a manufacturing or design defect that might lead to peri-implantitis occurring and escaping the available detections has been assessed and found remote and almost nonexistent.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.
Event or Problem Description
It was reported that the patient came in to the office saying that one of his implants at tooth site #10 felt painful and loose.We removed the implant and cleaned out the area.The implant was replaced.An additional appointment was anticipated for a three-month examination.Symptoms as a result of the event: inflammation and pain.
Additional Manufacturer Narrative
This report is being submitted to relay corrected data and additional information.Correction: d4 lot, product expiration date, product unique device identifier # were updated.G3 pma/510(k) # number was updated.H4 device manufacturer date was updated.The following sections are being reported: b4: date of this report was updated.D4: device lot number was updated.D4: device expiration was updated.D4: unique device identifier # was updated.G3: date received by manufacturer was updated.G3: device pma/510(k) # was updated.G6: type of report was updated.H2: type of follow up was updated.H4: device manufacture date was updated.H10: narrative/data was updated.
Event or Problem Description
No additional event information received at the time of this report.
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 corrected data, additional information and device evaluation.(b)(4).Dhr review was completed for the subject lot number.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 for similar events and no other complaint was identified.As documented in the summary investigations, contributing factors for the reported event likely exist outside of zimvie control, including those related to patient biological factors/condition and surgical technique.Based on the summary investigations, no malfunction occurred upon investigation.The reported event remains non-verifiable as they are a medical condition.Monthly trending to date has not identified any statistical triggers suggesting potential design or manufacturing related issues.Previously completed investigations for infection, bone loss, and/or peri-implantitis problems reported in association with implant failure have not identified any signals indicating potential non-conformances impacting the manufacturing and sterilization processes.Therefore, escalation to capa is not required.

• Brand Name: TSX IMPLANT, 4.7MMD, 10MML
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: mark mashburn ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 23720325
• Report Number: 0001038806-2025-03580
• Device Sequence Number: 18351682
• Product Code: DZE
• UDI-Device Identifier: 00844868045069
• UDI-Public: (01)00844868045069(17)241120(10)1259705
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K220978
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 02/03/2026

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: 11/20/2024
• Device Catalogue Number: TSX47B10
• Device Lot Number: 1259705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/04/2025
• Supplement Report FDA Received Date: 12/05/2025; 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2025
• 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: 43 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic