MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK, INC. KYPHON CEMENT DELIVERY SYSTEM; DISPENSER, CEMENT

Model Number	CDS2A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by staff, "the cement gun was unable to pump cement appropriately.Issue discovered on priming of gun.A new gun was opened and used" to complete procedure.

• Brand Name: KYPHON CEMENT DELIVERY SYSTEM
• Common Device Name: DISPENSER, CEMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK, INC.; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 10401071
• Report Number: 10401071
• Device Sequence Number: 2990661
• Product Code: KIH
• UDI-Device Identifier: 00643169463448
• UDI-Public: (01)00643169463448
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 08/03/2020
• Report Date (Section F): 08/03/2020

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
• Operator of Device: Other
• Device Model Number: CDS2A
• Device Catalogue Number: CDS2A
• Device Lot Number: 0219797876
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 66
• Date Report Sent to FDA: 08/03/2020