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

Model Number	503308BL
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Failed osteointergrate.

• Brand Name: INFINITY OCTAGON BONE LEVEL
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): HAGER & MEISINGER GMBH; hansemannstrabe 10; 4146 neuss, postfach 41429 ; GM 41429
• Manufacturer (Section G): HAGER & MEISINGER GMBH; hansemannstrabe 10; 41468 neuss, postfach 41429 ; GM 41429
• MDR Report Key: 17031622
• Report Number: 1287163-2023-54009
• Device Sequence Number: 7011987
• Product Code: DZE
• UDI-Device Identifier: E0HM503308BL1
• UDI-Public: E0HM503308BL1
• 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: Manufacturer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/28/2023

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
• Device Model Number: 503308BL
• Device Catalogue Number: 503308BL
• Device Lot Number: A76463
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/31/2023
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female