MAUDE Adverse Event Report: HERAEUS MEDICAL GMBH PALACOS MV+G; MIXER, CEMENT, FOR CLINICAL USE

Model Number MV+G PRO 80

Device Problems Device Difficult to Setup or Prepare (1487); Improper Flow or Infusion (2954)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2022

Event Type  malfunction  

Event Description

Liquid activator didnt transfer to cement powder within enclosed system.

• Brand Name: PALACOS MV+G
• Type of Device: MIXER, CEMENT, FOR CLINICAL USE
• Manufacturer (Section D): HERAEUS MEDICAL GMBH; 4130 parklake ave; suite 600; raleigh NC 27612
• MDR Report Key: 15923535
• MDR Text Key: 304882876
• Report Number: 15923535
• Device Sequence Number: 1
• Product Code: JDZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MV+G PRO 80
• Device Catalogue Number: 5081291
• Device Lot Number: 9009331615
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/30/2022
• Date Report to Manufacturer: 12/06/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29565 DA