MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. KYPHON V VERTEBROPLASTY KIT; DISPENSER, CEMENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Neuropathy (1983)

Event Type  Injury  

Manufacturer Narrative

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.Although it is unknown whether the alleged product caused or contributed to the reported event, we are filling this mdr for notification purpose.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported via safety aggregate retrospective data collected from a facility that 40 patients underwent vertebroplasty procedure.Post-op, two adverse events were reported.One adverse event was reported for an osteoporotic patient and the other was reported for a cancer patient.The osteoprotic patient with 2 vertebra treated developed florid spondylodiscitis (mimicking degenerative disk disease) of treated levels (no biological sign of infection in this cancer patient with osteoporotic fractures) and demised.Mri follow up was at 17 days post vertebroplasty.The cancer patient with several levels treated developed radicular pain immediately after vertebroplasty (6 vertebra) due to millimetric cortical displacement by needle at the vertebral recess coming into contact with nerve root.This radiculopathy completely resolved after periradicular infiltration.

• Brand Name: KYPHON V VERTEBROPLASTY KIT
• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 10121296
• MDR Text Key: 194114135
• Report Number: 1030489-2020-00575
• Device Sequence Number: 1
• Product Code: KIH
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other