MAUDE Adverse Event Report: HAGER & MEISINGER GMBH INFINITY OCTAGON; DENTAL IMPLANT

Model Number	504810
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Failed to osseointegrate & became loose.

• Brand Name: INFINITY OCTAGON
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): HAGER & MEISINGER GMBH; hansemannstrasse 10; neuss 41468 ; GM 41468
• MDR Report Key: 17316630
• Report Number: 1287163-2023-02209
• Device Sequence Number: 3995926
• Product Code: DZE
• UDI-Device Identifier: E0HM5048101
• UDI-Public: E0HM5048101
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 07/10/2023
• Report Date (Section F): 07/10/2023

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 Model Number: 504810
• Device Catalogue Number: 504810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/21/2023
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/13/2023
• 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: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Date Report Sent to FDA: 07/10/2023