MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHON® HV-R® BONE CEMENT; CEMENT, BONE, VERTEBROPLASTY

Model Number	C01B
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Dyspnea (1816); Extravasation (1842)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other - pulmonary embolism.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional via manufacturer representative regarding a patient implanted with bone cement used in kyphoplasty procedure.It was reported that the patient underwent a successful kyphoplasty and presented with shortness of breath approximately 3-4 weeks p ost-procedure.Imaging showed pulmonary embolism.Patient being symptomatic indicated extravasation.There was cement leak within the vertebral body to a vein.No further complications were reported/anticipated.

• Brand Name: KYPHON® HV-R® BONE CEMENT
• Common Device Name: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 15238430
• Report Number: 1030489-2022-00779
• Device Sequence Number: 6456866
• Product Code: NDN
• UDI-Device Identifier: 00643169097834
• UDI-Public: 00643169097834
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K041584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: C01B
• Device Catalogue Number: C01B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 08/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female