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

Model Number CDS2A

Device Problems Failure to Prime (1492); Pumping Problem (3016)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2020

Event Type  malfunction  

Event 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
• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK, INC.; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 10401071
• MDR Text Key: 202701472
• Report Number: 10401071
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 00643169463448
• UDI-Public: (01)00643169463448
• 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: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CDS2A
• Device Catalogue Number: CDS2A
• Device Lot Number: 0219797876
• 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: 08/03/2020
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26280 DA
• Patient Weight: 66