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

Model Number	504808
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Not enough bone to place the implant.

• Brand Name: INFINITY
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): HAGER & MEISINGER; hansemannstrasse 10; neuss, 41468 ; GM 41468
• MDR Report Key: 22345199
• Report Number: 1287163-2025-52399
• Device Sequence Number: 8573254
• Product Code: DZE
• UDI-Device Identifier: E0HM5048081
• UDI-Public: E0HM5048081
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 06/26/2025
• Report Date (Section F): 06/26/2015

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: 504808
• Device Catalogue Number: 504808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/28/2025
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2025
• 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: Other
• Patient Age: 83 YR
• Patient Sex: Male
• Date Report Sent to FDA: 06/26/2015