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

Model Number	504112BL
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant was placed (b)(6) 2022, placed locater on (b)(6) 2022 during final torque implant slightly turned so we did not engage denture to locater then the implant failed.

• Brand Name: INFINITY OCTAGON
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): HAGER & MEISINGER GMBH; hansemannstrasse 10; neuss 41468 ; GM 41468
• MDR Report Key: 17137543
• Report Number: 1287163-2023-02191
• Device Sequence Number: 3893103
• Product Code: DZE
• UDI-Device Identifier: E0HM504112BL1
• UDI-Public: E0HM504112BL1
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 06/15/2023
• Report Date (Section F): 06/15/2023

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: 504112BL
• Device Catalogue Number: 504112BL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/19/2023
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2023
• 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: 69 YR
• Patient Sex: Female
• Date Report Sent to FDA: 06/15/2023