MAUDE Adverse Event Report: ZIMVIE US CORP LLC TSX IMPLANT, 5.4MMD, 10MML; DENTAL IMPLANT

Catalog Number	TSX54B10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Osteolysis (2377)
Date of Event	02/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: weight unknown / not provided.D4: lot number unknown / not provided.A summary investigation has been completed for bone loss 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 bone loss have not identified any signals indicating potential non-conformances affecting the manufacturing and sterilization processes.Furthermore, the probability of manufacturing or design defects that might lead to bone loss and escaping the available detections has been assessed and found remote and almost non-existent.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 for their checkup showing mobility and inflammation around the implant at tooth site #19.The implant was removed due to bone loss.Symptoms as a result of the event: pain and inflammation.
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.The following sections are being reported: b4: date of this report was updated.D4: lot number, unique device identifier (udi) number and expiration date were updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H4: device manufacture date was updated.H11: narrative/data was updated.

• Brand Name: TSX IMPLANT, 5.4MMD, 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: 24746336
• Report Number: 0001038806-2026-01722
• Device Sequence Number: 18497430
• Product Code: DZE
• UDI-Device Identifier: 00844868045212
• UDI-Public: (01)00844868045212(17)300525(10)2120032797
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2026
• Device Explanted Year: 2026
• 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): 04/09/2026

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 Catalogue Number: TSX54B10
• Device Lot Number: 2120032797
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/20/2026
• 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: 03/31/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2025
• 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: 70 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic