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

Model Number	504110BL
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was a smoker, failed to osseointegrate.

• Brand Name: INFINITY OCTAGON IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): HAGER & MEISINGER; hansemannstr. 10; 41468 neuss, postfach 41429 ; GM 41429
• MDR Report Key: 16600544
• Report Number: 1287163-2022-53088
• Device Sequence Number: 7118664
• Product Code: DZE
• UDI-Device Identifier: E0HM504110BL1
• UDI-Public: E0HM504110BL1
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/23/2023
• Report Date (Section F): 03/23/2023

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: 504110BL
• Device Catalogue Number: 504110BL
• Device Lot Number: B50627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/07/2022
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/11/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2023
• 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: 58 YR
• Patient Sex: Male
• Date Report Sent to FDA: 03/23/2023