MAUDE Adverse Event Report: HERAEUS MEDICAL GMBH PALACOS BONE CEMENT WITH ANTIBIOTIC

Model Number	5081287
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject id: (b)(6).Study no: (b)(6).Clinical adverse event received for neck oa.Device and procedure (relatedness).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PALACOS BONE CEMENT WITH ANTIBIOTIC
• Common Device Name: BONE CEMENT
• Manufacturer (Section D): HERAEUS MEDICAL GMBH
• MDR Report Key: 21840072
• Report Number: MW5169023
• Device Sequence Number: 8642386
• Product Code: LOD
• UDI-Device Identifier: 04260102136151
• UDI-Public: 04260102136151
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Voluntary
• Initial Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date (Section B): 04/10/2025

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
• Device Model Number: 5081287
• Device Lot Number: 9010372228
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/15/2025
• Patient Sequence Number: 1
• Patient Sex: Unknown