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

Model Number BLT504110

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

Patient Problem Failure of Implant (1924)

Event Date 06/05/2023

Event Type  Injury  

Event Description

Had to change implant size to achieve stability.

• Brand Name: INFINITY OCTAGON
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): HAGE & MEISINGER GMBH; hansemannstrasse 10; neuss 41468 ; GM 41468
• MDR Report Key: 17277115
• MDR Text Key: 318555021
• Report Number: 1287163-2023-02205
• 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: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BLT504110
• Device Catalogue Number: BLT504110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/06/2023
• Distributor Facility Aware Date: 06/14/2023
• Device Age: 1 YR
• 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: 76 YR
• Patient Sex: Male