MAUDE Adverse Event Report: ZimVie US Corp LLC TSX IMPLANT, 3.1MMD, 10MML; Dental Implant

Catalog Number	TSX31B10
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994)
Date of Event	06/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported after implant placement at tooth site 4, patient continued to have severe pain.This was a redo of a previously placed and failed implant.It was decided by patient and doctor to remove this implant to alleviate pain.Doctor indicated allergic reaction.Possible implant placement in the future.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).

• Brand Name: TSX IMPLANT, 3.1MMD, 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 ; +1(561)971-3230
• MDR Report Key: 50300751
• Report Number: 0001038806-2026-04310
• Device Sequence Number: 18822305
• Product Code: DZE
• UDI-Device Identifier: 00844868044994
• 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: Dentist
• Type of Report: Initial
• Report Date (Section B): 08/18/2026

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: Lay User/Patient
• Device Catalogue Number: TSX31B10
• Device Lot Number: 2120034212
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 160 LB