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

Model Number	503310BL
Medical Device Problem Codes	Failure to Osseointegrate (1863); Loss of Osseointegration (2408); Osseointegration Problem (3003); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
No integration.

• Brand Name: INFINITY OCTAGON IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): HAGER & MEISINGER GMBH; hansemannstr. 10; neuss, 41468 ; GM 41468
• MDR Report Key: 17009533
• Report Number: 1287163-2023-54084
• Device Sequence Number: 7549593
• Product Code: DZE
• UDI-Device Identifier: E0HM503310BL1
• UDI-Public: E0HM503310BL1
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section F): 05/26/2023

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: 503310BL
• Device Catalogue Number: 503310BL
• Device Lot Number: B95261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/28/2023
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2023
• 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: 64 YR
• Patient Sex: Female
• Date Report Sent to FDA: 05/26/2023