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

Model Number	Z5C-40-12
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	06/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
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: ralf lüttmann ; werkhofstrasse 5; oensingen, solothurn 4702 ; SZ 4702
• MDR Report Key: 12859656
• Report Number: 3006948427-2021-00441
• Device Sequence Number: 4205290
• Product Code: DZE
• UDI-Device Identifier: 07640166760429
• UDI-Public: 07640166760429
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: Z5C-40-12
• Device Catalogue Number: Z5C-40-12
• Device Lot Number: 17477
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2019
• 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
• Patient Age: 74 YR
• Patient Sex: Female