MAUDE Adverse Event Report: ZimVie US Corp LLC IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM; Dental Implant

Catalog Number	TSVB10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the collar of implant has a crack at tooth site 4.Implant was removed due to fracture.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).G4: premarket identification k011028/k013227.

• Brand Name: IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
• 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: 50264402
• Report Number: 0001038806-2026-04278
• Device Sequence Number: 10285975
• Product Code: DZE
• UDI-Device Identifier: 00889024019508
• UDI-Public: (01)00889024019508(17)261118(10)1250166
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K061410
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 08/15/2026

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: TSVB10
• Device Lot Number: 1250166
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/03/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 08/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2021
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 150 LB