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

Model Number	Z5M-40-12
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	06/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Poor bone quality and adjacent teeth with deficient restoration (possibly infected).Possible biomechanical overload due to free end crown in the posterior region.

• 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: 20065120
• Report Number: 3006948427-2024-00183
• Device Sequence Number: 7728765
• Product Code: DZE
• UDI-Device Identifier: 07640166760146
• UDI-Public: 07640166760146
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120793
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 08/26/2024

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: 05/31/2022
• Device Model Number: Z5M-40-12
• Device Catalogue Number: Z5M-40-12
• Device Lot Number: 17373
• 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: 07/26/2024
• Initial Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2017
• 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: 72 YR
• Patient Sex: Female