MAUDE Adverse Event Report: ZimVie US Corp LLC TSX IMPLANT, 3.1MMD, 11.5MML; Dental Implant

Catalog Number	TSX31B11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	08/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced pain since implant placement.The patient returned for a follow-up today and stated that the pain had decreased over the past 2 days, but the gums were sore to touch.The implant failed to integrate and an infection was observed.As a consequence, the implant was removed, the infection was cleaned, and a bone graft was placed.Tooth site 11.Patient suffered from pain.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A2: age at time of the event unknown / not provided.A4: patient weight 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, 3.1MMD, 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 ; +1(561)971-3230
• MDR Report Key: 50750984
• Report Number: 0001038806-2026-04749
• Device Sequence Number: 12977279
• Product Code: DZE
• UDI-Device Identifier: 00844868029151
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• 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 Expiration Date: 09/24/2020
• Device Catalogue Number: TSX31B11
• Device Lot Number: 2120037944
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/21/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2015
• 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 Sex: Female