MAUDE Adverse Event Report: Z-SYSTEMS AG Z5; ENDOUSSEOUS DENTAL IMPLANT ROOT FORM

Model Number	Z5M-40-08LB
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Loss of osseointegration.

• 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: stephan kyburz ; werkhofstrasse 5; oensingen, 4702 ; SZ 4702
• MDR Report Key: 23278016
• Report Number: 3006948427-2025-00279
• Device Sequence Number: 12152447
• Product Code: DZE
• UDI-Device Identifier: 07640166760221
• UDI-Public: 07640166760221
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131701
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• 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): 10/13/2025

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: Z5M-40-08LB
• Device Catalogue Number: Z5M-40-08LB
• Device Lot Number: 17092
• 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: 09/16/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2013
• 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: 67 YR
• Patient Sex: Female