MAUDE Adverse Event Report: ZimVie US Corp LLC IMP,TSV,MCOL MG,4.7MM,11.5MML; Dental Implant

Catalog Number	TSVMWB11
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Inflammation (1932); Osteolysis (2377)
Date of Event	07/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient showed bone loss around implant.The crown was removed and the implant was found to be broken, so it was removed.Patient suffered from inflammation.Procedure was not completed.
Additional Manufacturer Narrative
Zimvie complaint number (b)(6).A4: patient weight unknown / not provided.D9: device availability unknown / not provided.G4: premarket identification k101880.

• Brand Name: IMP,TSV,MCOL MG,4.7MM,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: 50032321
• Report Number: 0001038806-2026-03914
• Device Sequence Number: 18619001
• Product Code: DZE
• UDI-Device Identifier: 00889024019782
• UDI-Public: (01)00889024019782(17)280802(10)1271048
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K111889
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: TSVMWB11
• Device Lot Number: 1271048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2023
• 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
• Patient Age: 58 YR
• Patient Sex: Male