MAUDE Adverse Event Report: ZimVie US Corp LLC IMP,TSV,4.1MM,SBM,10; Dental Implant

Catalog Number	TSV4B10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	04/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient had a 4.1×10 mm implant placement.The patient recently returned for a follow-up due to discomfort; images revealed a crack in the implant, and it was subsequently removed.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).D6: d6a.If implanted, unknown.D9: device availability unknown / not provided.

• Brand Name: IMP,TSV,4.1MM,SBM,10
• 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: 50928440
• Report Number: 0001038806-2026-04918
• Device Sequence Number: 9526255
• Product Code: DZE
• UDI-Device Identifier: 00889024019225
• UDI-Public: (01)00889024019225(17)270109(10)1251329
• 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 Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: TSV4B10
• Device Lot Number: 1251329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2022
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 143 LB