MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK, INC. KYPHON V PREMIUM VERTEBROPLASTY; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	VPT13D
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Hub of vertebroplasty needle fractured from the body of the needle.Needle was successfully removed.

• Brand Name: KYPHON V PREMIUM VERTEBROPLASTY
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK, INC.; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 12525448
• Report Number: 12525448
• Device Sequence Number: 11787724
• Product Code: LXH
• UDI-Device Identifier: 00763000026820
• UDI-Public: (01)00763000026820
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 09/10/2021
• Report Date (Section F): 09/10/2021

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: Health Professional
• Device Model Number: VPT13D
• Device Lot Number: 218856893
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/24/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2021
• Patient Sequence Number: 1
• Patient Weight: 112
• Date Report Sent to FDA: 09/10/2021