MAUDE Adverse Event Report: ZimVie US Corp LLC IMP,TSV,4.1MM,DUAL SEL,HA; Dental Implant

Catalog Number	TSV4H10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Osteolysis (2377)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury

• Brand Name: IMP,TSV,4.1MM,DUAL SEL,HA
• 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: 50646995
• Report Number: 0001038806-2026-04686
• Device Sequence Number: 18763128
• Product Code: DZE
• UDI-Device Identifier: 00889024019300
• UDI-Public: (01)00889024019300(17)291016(10)1286463
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072589
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/07/2026

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: TSV4H10
• Device Lot Number: 1286463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2024
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 149 LB