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

Model Number	BLT504810
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Seating the crown was painful.

• Brand Name: INFINITY
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): HAGER & MEISINGER GMBH; hansemannstrasse 10; neuss 41468 ; GM 41468
• Manufacturer (Section G): HAGER & MIESINGER GMBH; hansemannstrasse 10; neuss 41468 ; GM 41468
• Manufacturer Contact: eileen carpentieri ; 1034 pearl st; brockton, MA 02301 ; 8004413100
• MDR Report Key: 16808263
• Report Number: 1287163-2023-02151
• Device Sequence Number: 20331549
• Product Code: DZE
• UDI-Device Identifier: E0HMBLT5048101
• UDI-Public: E0HMBLT5048101
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 04/25/2023

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: BLT504810
• Device Catalogue Number: BLT504810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female