MAUDE Adverse Event Report: ZIMVIE US CORP LLC TSX IMPLANT, 4.7MMD, 11.5MML; DENTAL IMPLANT

Catalog Number	TSX47B11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Infection (1930); Osteolysis (2377)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant at tooth site #30 was removed due to bone loss and infection.Pt was seen in hygiene for recare.Reports he had swelling but never contacted provider.At recare, pt had abscess with exudate.Full thickness flap, implant backed out, removal of all granulation tissue and exudate, regrafting of site with allograft and membrane.Yes, waiting 5 months before placing new implant in #30 site.Symptoms as a result of the event: abscess, inflammation.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.B3: date of event unknown / not provided.E1: email unknown / not provided.H6: additional h6- patient codes: 1932: inflammation.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Similar complaints for infection and / or bone loss related problems have been previously investigated.Investigations performed for hundreds of events where either of these conditions, infection, or bone loss, or both, have been reported, have concluded that the likely cause(s) for the implant failure in relation to these conditions are external factors.Those include medical conditions (e.G., diabetes, bruxism, etc.), patient habits (e.G., smoking, bad oral hygiene routine) and user error (e.G., surgical technique).There has not been any instance where either infection and/or bone loss have resulted from a manufacturing or design defect.Furthermore, the probability of manufacturing or design defects that might lead to infection and result in bone loss occurring and escaping the available detections has been assessed and found remote and almost nonexistent.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.The analysis and result of investigations and the analysis of probability previously described are contained in the summary investigation reports performed for bone loss and infection, which are attached.Additionally, all device history record reviews verified that each implant was sterilized per procedure for every device.All complaint data used for the summary investigation was found to be conforming and did not meet capa/hhe/d/ or any further escalations.Therefore, there were no complaints which confirmed a manufacturing or design related issue that did or could cause or contribute to the reported event.Dhr review was completed for the subject lot number 1273437.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Sterilization record (b)(4) 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 1273437 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 events remain 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 and/or bone loss, 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.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, d9: device availability, g3: date received by manufacturer, g6: checked "follow-up", h6: entered evaluation codes, h10: added manufacturer narrative.

• Brand Name: TSX IMPLANT, 4.7MMD, 11.5MML
• 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: 24019326
• Report Number: 0001038806-2026-00161
• Device Sequence Number: 10550597
• Product Code: DZE
• UDI-Device Identifier: 00844868045168
• UDI-Public: (01)00844868045168(17)251002(10)1273437
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: 2025
• 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): 02/20/2026

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: 10/02/2025
• Device Catalogue Number: TSX47B11
• Device Lot Number: 1273437
• 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
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• 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: 80 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic