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

Model Number	MV PRO 80
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
When preparing the cement, the liquid portion of it would not transfer to the powder.New cement was opened and used; lot number of new cement opened unknown.No delay to case or harm to patient.

• Brand Name: PALACOS®
• Common Device Name: BONE CEMENT
• Manufacturer (Section D): HERAEUS MEDICAL GMBH; township line road 770; suite 300; yardley PA 19067
• MDR Report Key: 20180171
• Report Number: 20180171
• Device Sequence Number: 18377323
• Product Code: LOD
• UDI-Device Identifier: 04260102135369
• UDI-Public: 04260102135369
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/20/2024
• Report Date (Section F): 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MV PRO 80
• Device Catalogue Number: 5150635
• Device Lot Number: 9016243896
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/20/2024