MAUDE Adverse Event Report: ZimVie US Corp LLC IMP,TSV,MCOL MG,4.1MM,11.5MML; Dental Implant

Catalog Number	TSVM4B11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Osteolysis (2377)
Date of Event	08/11/2021
Type of Reportable Event	Serious Injury

• Brand Name: IMP,TSV,MCOL MG,4.1MM,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: 50647478
• Report Number: 0001038806-2026-04693
• Device Sequence Number: 10485138
• Product Code: DZE
• UDI-Device Identifier: 00889024019638
• UDI-Public: (01)00889024019638(10)63850006(17)221130
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K111889
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• 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 Expiration Date: 11/30/2022
• Device Catalogue Number: TSVM4B11
• Device Lot Number: 63850006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2017
• 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 Sex: Female