MAUDE Adverse Event Report: Z-Systems AG Z5; endousseous dental implant root form

Model Number	Z5-BL-3608
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Fracture: biomechanical overload.

• Brand Name: Z5
• Common Device Name: endousseous dental implant root form
• Manufacturer (Section D): Z-Systems AG; werkhofstrasse 5; oensingen, 4702 ; SZ 4702
• Manufacturer (Section G): Z-Systems AG; werkhofstrasse 5; oensingen, solothurn 4702 ; SZ 4702
• Manufacturer Contact: michaela ritzmann ; werkhofstrasse 5; oensingen, 4702 ; SZ 4702
• MDR Report Key: 50943207
• Report Number: 3006948427-2026-00329
• Device Sequence Number: 15840854
• Product Code: DZE
• UDI-Device Identifier: 07640166768463
• UDI-Public: 07640166768463
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: Health Professional
• Device Model Number: Z5-BL-3608
• Device Catalogue Number: Z5-BL-3608
• Device Lot Number: Z210010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2023
• 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
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 63 YR
• Patient Sex: Female