MAUDE Adverse Event Report: KEYSTONE DENTAL INC Z-MAX; Z-MAX IMPLANT ?8.0 X 11MM LENGTH

Model Number	Z-MAX8-11
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Loss of osseointegration.

• Brand Name: Z-MAX
• Common Device Name: Z-MAX IMPLANT ?8.0 X 11MM LENGTH
• Manufacturer (Section D): KEYSTONE DENTAL INC; 154 middlesex turnpike; burlington MA 01803
• MDR Report Key: 11177063
• Report Number: 3005990499-2021-25993
• Device Sequence Number: 11320666
• Product Code: DZE
• UDI-Device Identifier: D768ZMAX8110
• UDI-Public: +D768ZMAX8110/$$71014111402O
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/14/2021

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 Model Number: Z-MAX8-11
• Device Catalogue Number: Z-MAX8-11
• Device Lot Number: 1014111402
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Congenital Anomaly; Other; Required Intervention
• Patient Age: 47 YR