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

Model Number	Z5M-40-10LC-25
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	08/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
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: florin trifa ; werkhofstrasse 5; oensingen, solothurn 4702 ; SZ 4702
• MDR Report Key: 16288777
• Report Number: 3006948427-2022-00506
• Device Sequence Number: 17824767
• Product Code: DZE
• UDI-Device Identifier: 07640166760344
• UDI-Public: 07640166760344
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K131701
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• 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): 01/23/2023

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: 11/20/2020
• Device Model Number: Z5M-40-10LC-25
• Device Catalogue Number: Z5M-40-10LC-25
• Device Lot Number: 17273
• 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: 12/28/2022
• Initial Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2015
• 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: 52 YR
• Patient Sex: Female