MAUDE Adverse Event Report: ZimVie US Corp LLC IMP,TSV,3.7,11.5,MTX,MG; Dental Implant

Catalog Number	TSVTB11
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor reported fracture of implant collar at tooth site 46, fitted with a porcelain-fused-to-metal crown on hla 3/4 abutment.Doctor also indicated crown loss, a new zircon crown will be placed at tooth site 46.Implant was removed.
Additional Manufacturer Narrative
Zimvie complaint number(b)(4).A4: patient weight unknown / not provided.

• Brand Name: IMP,TSV,3.7,11.5,MTX,MG
• 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: 50018220
• Report Number: 0001038806-2026-03910
• Device Sequence Number: 10579329
• Product Code: DZE
• UDI-Device Identifier: 00889024019935
• UDI-Public: (01)00889024019935(17)241019(10)1232739
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101977
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 07/24/2026

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 Expiration Date: 10/19/2024
• Device Catalogue Number: TSVTB11
• Device Lot Number: 1232739
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/08/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2019
• 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: 76 YR
• Patient Sex: Male