MAUDE Adverse Event Report: ZimVie US Corp LLC TSX IMPLANT, 5.4MMD, 10MML; Implant, Endosseous, Root-Form

Catalog Number	TSX54B10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Purulent Discharge (1812); Unspecified Infection (1930)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient returned one month postoperatively following implant placement at tooth site 14 with an indirect sinus lift and presented with symptoms of a sinus infection and persistent drainage.The patient completed a course of antibiotics; however, the symptoms persisted.Sinus rinses were recommended, but the patient returned two weeks later with no improvement.Due to the persistent infection, the implant was removed, the maxillary sinus was cleaned, and a larger-diameter implant was placed.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4) a4: patient weight unknown / not provided 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.

• Brand Name: TSX IMPLANT, 5.4MMD, 10MML
• Common Device Name: Implant, Endosseous, Root-Form
• 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 ; +1(561)971-3230
• MDR Report Key: 50754214
• Report Number: 0001038806-2026-04764
• Device Sequence Number: 9241552
• Product Code: DZE
• UDI-Device Identifier: 00844868045212
• UDI-Public: (01)00844868045212(17)310121(10)4120004891
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: Health Professional
• Device Catalogue Number: TSX54B10
• Device Lot Number: 4120004891
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2026
• 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
• Patient Age: 58 YR
• Patient Sex: Female