MAUDE Adverse Event Report: ZIMVIE US CORP LLC TSX IMMEDIATE MOLAR IMPLANT, 8MMD, 8MML; DENTAL IMPLANT

Catalog Number	TSXIM8D8L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
It was reported that the implant at tooth site #30 was removed due to persistent pain.Patient states she has been having persistent pain ever since implant was placed.
Additional Manufacturer Narrative
Zimvie received one (1) tsxim8d8l (tsx® immediate molar implant, 8mmd, 8mml) for evaluation.Visual evaluation was performed.The implant had signs of use with debris on its internal and external threads.There was no damage identified or signs of malfunction that would have contributed to the event.Measurements match drawing dhr review was completed for the subject lot number 2120031018.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2120031018 for similar events and no other complaint was identified.The customer did not submit images for the reported event.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was patient factors.Therefore, based on the available information, a device malfunction did not occur.Implant was returned with no damage that would cause or contribute to the event.The reported event was non-verifiable with all the available information.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: TSX IMMEDIATE MOLAR IMPLANT, 8MMD, 8MML
• 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 23311076
• Report Number: 0001038806-2025-02469
• Device Sequence Number: 5789240
• Product Code: DZE
• UDI-Device Identifier: 00844868047766
• UDI-Public: (01)00844868047766(17)300429(10)2120031018
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K241753
• 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): 12/17/2025

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: TSXIM8D8L
• Device Lot Number: 2120031018
• 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: 10/16/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2025
• 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: 46 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic