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

Model Number	504108BL
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Failed to osseointegrate.

• Brand Name: INFINITY OCTAGON BONE LEVEL
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): HAGER & MEISINGER GMBH; hansemannstrabe 10; 41468 neuss, portfach 41429 ; GM 41429
• MDR Report Key: 16628882
• Report Number: 1287163-2022-53092
• Device Sequence Number: 5324249
• Product Code: DZE
• UDI-Device Identifier: E0HM504108BL1
• UDI-Public: E0HM504108BL1
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/24/2023
• Report Date (Section F): 03/24/2023

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: 504108BL
• Device Catalogue Number: 504108BL
• Device Lot Number: B66923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/07/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/14/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2023
• 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: 66 YR
• Patient Sex: Prefer Not To Disclose
• Date Report Sent to FDA: 03/24/2023