MAUDE Adverse Event Report: HAGER & MEISINGER GMBH INFINITY OCGTAGON; DENTAL IMPLAN T

Model Number 504808WP

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Failure of Implant (1924)

Event Date 07/25/2023

Event Type  Injury  

Event Description

Had to change to bone level implant.

• Brand Name: INFINITY OCGTAGON
• Type of Device: DENTAL IMPLAN T
• Manufacturer (Section D): HAGER & MEISINGER GMBH; hansemannstrasse 10; neuss 41468 ; GM 41468
• MDR Report Key: 17715597
• MDR Text Key: 323037050
• Report Number: 1287163-2023-02258
• Device Sequence Number: 1
• Product Code: DZE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 504808WP
• Device Catalogue Number: 504808WP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2023
• Distributor Facility Aware Date: 08/04/2023
• Event Location: Outpatient Treatment Facility
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female