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

Model Number	504108
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)
Date of Event	02/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Primary stability was achieved but implant did not integrate.

• Brand Name: INFINITY REGULAR PLATFORM OCTAGON IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): HAGER & MEISINGER GMBH; hansemannstr. 10; neuss, 41468 ; GM 41468
• MDR Report Key: 17260652
• Report Number: 1287163-2023-54047
• Device Sequence Number: 5911248
• Product Code: DZE
• UDI-Device Identifier: E0HM5041081
• UDI-Public: E0HM5041081
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 07/05/2023
• Report Date (Section F): 07/05/2023

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: 504108
• Device Catalogue Number: 504108
• Device Lot Number: B75210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/28/2023
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/05/2023
• 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: 56 YR
• Patient Sex: Male
• Date Report Sent to FDA: 07/05/2023