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

Model Number	Z5M-40-08
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	10/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Marginal bone loss, indicating peri-implantitis, large crown, 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: stephan kyburz ; werkhofstrasse 5; oensingen, 4702 ; SZ 4702
• MDR Report Key: 19960354
• Report Number: 3006948427-2023-00405
• Device Sequence Number: 8731385
• Product Code: DZE
• UDI-Device Identifier: 07640166760023
• UDI-Public: 07640166760023
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K120793
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 08/09/2024

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 Expiration Date: 05/25/2025
• Device Model Number: Z5M-40-08
• Device Catalogue Number: Z5M-40-08
• Device Lot Number: Z210112
• 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: 10/16/2023
• Initial Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2022
• 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: Disability
• Patient Age: 57 YR
• Patient Sex: Male