MAUDE Adverse Event Report: HERAEUS MEDICAL GMBH PALACOS®; BONE CEMENT

Model Number MV+G PRO 80

Device Problem Use of Device Problem (1670)

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

Event Date 05/10/2023

Event Type  malfunction  

Event Description

Palacos system didn't mix liquid and powder to make cement mixture and product was not usable.Patient not affected.Only product packaging available for return.

• Brand Name: PALACOS®
• Type of Device: BONE CEMENT
• Manufacturer (Section D): HERAEUS MEDICAL GMBH; township line road 770, suite 300; yardley PA 19067
• MDR Report Key: 17018728
• MDR Text Key: 316103634
• Report Number: 17018728
• Device Sequence Number: 1
• Product Code: LOD
• 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: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• 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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/24/2023
• Date Report to Manufacturer: 05/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28105 DA