MAUDE Adverse Event Report: Z5; ENDOUSSEOUS DENTAL IMPLANT ROOT FORM

Model Number	Z5M(T)-50-10
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	07/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Insufficient bone quality.

• Brand Name: Z5
• Common Device Name: ENDOUSSEOUS DENTAL IMPLANT ROOT FORM
• MDR Report Key: 12655621
• Report Number: 3006948427-2021-00372
• Device Sequence Number: 17184017
• Product Code: DZE
• UDI-Device Identifier: 07640166760542
• UDI-Public: 07640166760542
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 10/18/2021

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: 02/28/2026
• Device Model Number: Z5M(T)-50-10
• Device Catalogue Number: Z5M(T)-50-10
• Device Lot Number: Z200109
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 10/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2021
• 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: 45 YR